LIFEPAK® 500 Automated External Defibrillator
PHYSIO-CONTROL, INC. · Model 99401
LP500AAABAZZZZZLP500EECGIAAAAAAZZZZZ
Intended use: A portable electronic device designed to automatically detect cardiac arrhythmias (ventricular fibrillation/pulseless ventricular tachycardia) in a sudden cardiac arrest (SCA) patient, after which it audibly/visually instructs an operator to enable it to activate defibrillation of the heart through application of electrical shocks to the chest surface. It is placed in conspicuous public locations and is intended to be operated by a layperson. It consists of two skin-adhesive, cartridge-type, disposable electrodes containing non-rechargeable batteries that provide the shock energy, and an electrode-regulating external pulse generator (EPG), which may include a CPR feedback.
Key tips
- ·Never skip the daily/shift ready-check - a defibrillator found dead during a code is a real, repeated root-cause finding.
- ·Pads and batteries have real expiration dates - check them on every PM, not just at annual service.
- ·Verify energy-delivery accuracy with a real defibrillator analyzer, not just a self-test pass.
Typical Failure Modes
Failure patterns typical of this equipment class - general BMET reference, not verified against this exact unit's own service history unless flagged. Severity is a category-level estimate.
High-voltage capacitor failure
HighSymptoms: Charge fails or sluggish, low-energy delivery.
Root cause: Capacitor aging / leakage.
Battery degradation
HighSymptoms: Short charge-hold, low-battery on readiness test.
Root cause: Aged battery pack.
Paddle / electrode fault
HighSymptoms: No shock delivered, pad error.
Root cause: Worn paddles or expired pads.
Charge / discharge relay fault
HighSymptoms: Won't charge or discharges unexpectedly.
Root cause: Relay/contactor wear.
Serviceable Parts & Consumables
The parts a BMET typically services on this class of equipment. Service class and relative cost are general engineering estimates for the category, not figures from this unit's documentation. Part numbers appear only when pulled from this unit's own service manual. Always confirm intervals and pricing against the manufacturer.
Charge relay / contactor
Class Periodic replacementRel. cost $$$R&R Difficult
Patient interface cable
Class Periodic replacementRel. cost $$R&R Fairly easy
Rechargeable battery pack
Critical, keep charged spares.
Class Periodic replacementRel. cost $$$R&R Fairly easy
HV energy storage capacitor
Class Major service partRel. cost $$$$R&R Expert-level
| Part | Service class | Relative cost | R&R difficulty |
|---|---|---|---|
| Charge relay / contactor | Periodic replacement | $$$ | Difficult |
| Patient interface cable | Periodic replacement | $$ | Fairly easy |
| Rechargeable battery pack Critical, keep charged spares. | Periodic replacement | $$$ | Fairly easy |
| HV energy storage capacitor | Major service part | $$$$ | Expert-level |
Relative cost: $ lowest · $$$$ highest service-part cost for this equipment class. Not a price.
PM Checklist
Preventive-maintenance tasks typical of this equipment class. Perform to the manufacturer's procedure and your facility's policy - this is general reference, not a schedule for this specific unit.
- ·Daily/shift visual and self-test check (AAMI EQ56 daily-ready standard)
- ·Battery and pad expiration-date tracking
- ·Energy-delivery accuracy test against a defibrillator analyzer
- ·Paddle/cable continuity check
- ·Annual full PM
Troubleshooting Approach
A structured starting point derived from the failure modes above. Follow the manufacturer's service documentation for the actual procedure.
Symptom: High-voltage capacitor failure
- Confirm the presentation - typically charge fails or sluggish, low-energy delivery - and note the exact alarm or message and the conditions when it occurs.
- Check the most likely cause first: capacitor aging / leakage.
- Isolate the affected subsystem using the manufacturer's functional check or self-test, where one is provided.
- If the fault is confirmed and not a field adjustment, service or replace the rechargeable battery pack per the manufacturer's service documentation.
- Return the device to service only after the manufacturer's functional and applicable electrical-safety checks pass.
- Record the findings, any parts used, and the verification results in the maintenance history.
Symptom: Battery degradation
- Confirm the presentation - typically short charge-hold, low-battery on readiness test - and note the exact alarm or message and the conditions when it occurs.
- Check the most likely cause first: aged battery pack.
- Isolate the affected subsystem using the manufacturer's functional check or self-test, where one is provided.
- If the fault is confirmed and not a field adjustment, service or replace the hV energy storage capacitor per the manufacturer's service documentation.
- Return the device to service only after the manufacturer's functional and applicable electrical-safety checks pass.
- Record the findings, any parts used, and the verification results in the maintenance history.
Technical Specs
- MRI safety
- MR Unsafe
- Sterile
- No
- Single use
- No
- Prescription use
- Rx only
- FDA distribution status
- Not in Commercial Distribution
- Device type (GMDN)
- Non-rechargeable public semi-automated external defibrillator
- FDA product classification
- Automated external defibrillators (non-wearable)
- Manufacturer support
- +1(800)442-1142 · rs.seacustomersupport@physio-control.com
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
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
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
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
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 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
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 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.
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