LIFEPAK® 500 Automated External Defibrillator

Typical Location

Where this class of equipment is typically deployed - general reference, not this unit's own placement record.

• Crash carts (every unit)
• Emergency Department
• ICU
• OR
• Code-blue response areas

Documents & Manuals

No documents available for this device yet.

Safety & Recalls

Synced live from the FDA openFDA API.

• RECALL

  Due to required inspections not being performed on products/units that have gone through servicing.

• RECALL

  Due to an error message that prevents users from utilizing carboxyhemoglobin saturation and methemoglobin saturation sensors on their monitor/defibrillator system.

• RECALL

  Due to an out of tolerance tool being used on monitor/defibrillator systems.

• RECALL

  AC Power Adapter (ACPA) may not charge the monitor/defibrillator batteries and may not allow the monitor/defibrillator to power on while plugged into the ACPA.

• RECALL

  Due to complaints received regarding missing lid magnets which may result in premature battery depletion.

• RECALL

  Packaging of infant child reduced energy electrodes was not properly sealed.

• RECALL

  Automated External Defibrillators may not detect a patient connection due to mechanical wear-through of the contact plating on the therapy connector. The wear-through could result in the device not recognizing a patient is connected which could result in a delay in treatment

• RECALL

  Monitor/Defibrillator may not deliver a shock after the "Shock" button on the keypad is pressed as a result of oxidation that has formed over time within the button.

• RECALL

  Certain LIFEPAK 15 Monitors/ Defibrillators were reported to experience a lockup condition after a shock was delivered. This condition is defined as a blank monitor display with LED lights on, indicating power on the device, but no response in keypad and device functions.

• RECALL

  Physio-Control is aware that some devices have had power-related failures as customers prepared their device for initial deployment or during use within the first year of distribution. The symptoms of these failures may include unexpected power on and power off, device lock-up, or a failure to power on or off, any of which has the potential to result in a failure to deliver therapy to the patient and serious injury or death.

• RECALL

  The infant artwork on the product instructs incorrect pad placement. Also, the artwork is missing the Type BF Patient connection and High Voltage Warning symbols.

• RECALL

  The End-Tidal CO2 (EtCO2) reading can intermittently show a value of XXX after start-up or during device operation.

• RECALL

  The firm has received complaints that the LIFEPAK 1000 Defibrillator is unexpectedly powering off during device usage.

• RECALL

  The firm has become aware of a potential device issue where the LIFEPAK 15 device may no longer be able to deliver defibrillation energy due to a potential failure of an internal component (Relay) installed on the Therapy Printed Circuit Board Assembly (PCBA).

• RECALL

  LIFEPAK CR Plus Automated External Defibrillators (AED) or LIFEPAK EXPRESS AED may fail to initiate voice prompts when the ON/OFF button is pressed and the lid is opened due to an internal component (reed switch) that can intermittently become fixed in the closed position. A defibrillator in this condition will fail to deliver a shock, with the potential result that therapy is not delivered and a patient is not resuscitated.

• RECALL

  Physio-Control has become aware of incidents where customers have attempted to use their LIFEPAK 1000 defibrillator and the device has shut down unexpectedly due to a very low battery. A defibrillator in this scenario has the potential to fail to deliver a shock, with the potential result that therapy is not delivered and a patient is not resuscitated. A software malfunction in the LIFEPAK 100

• RECALL

  The LIFEPAK 500 Automated External Defibrillator (AED) could be susceptible to malfunction due to an assembly error. If affected, the malfunction would be the result of internal shorting on a printed circuit board assembly and could render the device inoperable.

• RECALL

  LIFEPAK CR Plus or LIFEPAK Express Automated External Defibrillators (AEDs) are recalled due to the potential to experience an early internal battery depletion issue.

• RECALL

  The potential reliability issue is the result of a design characteristic of a SRAM (Static Random Access Memory) electronic component on the main printed circuit board assembly.

• RECALL

  The 12-lead ECG cables have experienced premature failures which cause the shielding and conductors to break internally creating ECG noise or "lead off" indications.

• RECALL

  L1FEPAK 12 Operating Instructions that describe the process for disconnecting the device from AC (wall) power are not always being followed. When the instructions are not followed and the Power ON button is pushed within 2 seconds after disconnecting the device from AC power, the service indicator will illuminate and the device may fail to charge the defibrillator and/or initiate pacing.

• RECALL

  A component failure on the AC power supply assembly results in "NO AC POWER" operation. A failure of AC power can result in a delay of defibrillation therapy if backup battery power is depleted.

• RECALL

  A failure on the power supply assembly can result in either "No DC power" or "No DC or AC power." A failure of DC (battery) power can result in a delay of defibrillation therapy if no AC (line) power is available and the device will not operate.

• RECALL

  Customer complaint was received relating to a LifePak15 device that would power on then power down unexpectedly after a short period of use. When the LP15 powered down, power could be immediately restored by activation of the power button. The device was connected to a cellular modem from MultiTech systems for use with LIFE NET services. The corrective action was completed by Velocitor Solutions in December 2010.

• RECALL

  Potential for the device to power off then on by itself, or to power off by itself and requiring the operator to turn it back on, or the device doesn't turn off.

• RECALL

  Some LIFEPAK 15 Monitor/Defibrillators have a Non-Invasive Blood Pressure (NIBP) module that was supplied by CAS Medical Systems, Branford, Connecticut who is recalling the modules. The NIBP modules may be susceptible to sudden changes in cuff pressure. Sudden changes in cuff pressure may possibly be caused by bumping or squeezing the cuff. In some instances this may result in a screen display

• RECALL

  The K1 relay on the Analog printed circuit board assembly may short due to moisture ingress in a highly humid environment. K1 shorting may affect the ECG amplitude causing the Shock Advisory System(SAS) to not analyze the ECG rhythm correctly thus preventing the device from delivering therapy.

• RECALL

  Affected devices contain a Biphasic PCBA that may have a solder defect on the H Bridge component that could prevent the device from providing a defibrillation shock. There could be a delay in therapy or prevention of defibrillation therapy if the defibrillator were needed in a cardiac arrest situation. Delay or prevention of defibrillation therapy may contribute to the death of a viable patient.

• RECALL

  When users do not disconnect the test plug and reconnect the QUIK-COMBO electrodes to the therapy cable, the test plug signal can be misinterpreted as a patient waveform.

• RECALL

  Sterilization efficacy could not be confirmed for sterilization methods on External Sterilizable Paddles and Pediatric Paddle attachments.

• RECALL

  This recall is being conducted due to the device being configured with the incorrect software for semi-automatic instead of fully automatic use. When the device is needed for a cardiac arrest emergency, the device will require that the user press the shock button instead of automatically delivering a shock as per the normal operation of the fully automatic device. Fully automatic defibrillators h

• RECALL

  The device may not power on although it indicates it is ready for use and would not be able to provide defibrillation therapy.

• RECALL

  Potential for the coin battery to drain prematurely causing the monitor clock time and date to be incorrect and the service light indicator to illuminate.

• RECALL

  A thicker keypad may prevent the door from fully latching closed. If the door is not fully closed, there is a potential that the defibrillator will not automatically change from automatic external defibrillation (AED) mode to manual mode by pressing the "MANUAL" button located on the lower left corner of the door. This may lead to a delay in defibrillation therapy.

• RECALL

  The LIFEPAK12 defibrillator/monitor series (LP12) contain a Biphasic PCBA that may have a solder defect on the H Bridge component that could prevent the device from providing a defibrillation shock.

• RECALL

  The LIFEPAK 12 defibrillator / monitors with software version 130 have an increase in likelihood for an incorrect Shock Advisory Algorithm (SAS) decision if the Auto Analyze setting in AED mode is On, leading to incorrectly render of shock or no shock decision. When Auto Analyze is set to On in AED mode the device initiates the SAS analysis immediately (no waiting period or warning prior to analys

• RECALL

  Batteries mislabeled - batteries labeled as 2.4 amp/hour batteries, however are 1.0 amp/hour batteries.

• RECALL

  Potential for the display screen to dim and eventually go blank. The risk to patient is a delay in defibrillation therapy if the defibrillator was needed in a cardiac arrest situation. Death or permanent impairment can occur if the user fails to deliver a defibrillation shock or defibrillation is delayed.

• RECALL

  Based on testing, sterilization methods described in labeling may be ineffective and may cause damage or corrosion to the paddles or handles. If handles and/or paddles are not sterilized adequately and are used on a patient, there is a risk of infection. If handle discharge button is damaged during sterilization, defibrillation therapy may be prevented.

• RECALL

  Inoperable Device - Potential for delay in therapy or prevention of defibrillation therapy due to corrosion of the Printed Circuit Board Assemblies (PCBA).