PHYSIO-CONTROL, INC. · Model 97403
ASSY-LPCR PLUS, AUTO, ENGLISH, AHA2005.
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 automatically activates defibrillation of the heart through application of electrical shocks to the chest surface. The device is placed in conspicuous public locations and is intended to be applied to the patient by a layperson. It consists of an external pulse generator (EPG) with a cardiac rhythm recognition system and a pair of skin-adhesive electrodes to monitor the rhythm and deliver the shocks; it includes internal rechargeable batteries for energy that must be charged when not in use.
Compiled for this model from its own documentation and established engineering knowledge for this equipment class - not from a verified service record. Confirm against the manufacturer's service manual.
Symptoms: Delivered energy outside tolerance on the analyser, will not charge, or charges slowly.
Root cause: HV capacitor / charging-circuit ageing, or an output-relay fault.
Symptoms: Short standby, readiness indicator shows service, unit fails the self-test on battery.
Root cause: Aged battery pack or a charging fault.
Symptoms: "Check pads", "connect electrodes", no ECG through pads, poor paceing capture.
Root cause: Worn therapy cable, expired pads, or a paddle / connector fault.
Symptoms: A monitoring parameter drops or is implausible.
Root cause: Patient cable / sensor or the parameter module.
Symptoms: No printout, event data will not transfer.
Root cause: Thermal recorder or the data / Wi-Fi interface.
Serviceable items for this model, compiled from its documentation and engineering knowledge for this equipment class. Service class and relative cost are estimates, not manufacturer figures; no part numbers are given. Confirm intervals and pricing against the manufacturer.
| Part | Service class | Relative cost | R&R difficulty |
|---|---|---|---|
| Battery pack | Periodic replacement | $$ | Easy |
| Therapy / defib cable | Periodic replacement | $$ | Fairly easy |
| Multifunction pads | Frequent wear item | $ | Easy |
| HV / charging board | Major service part | $$$$ | Difficult |
| Thermal recorder / print head | Periodic replacement | $$ | Fairly easy |
Relative cost: $ lowest · $$$$ highest service-part cost for this equipment class. Not a price.
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.
A starting sequence for this model, compiled from its documentation and engineering knowledge for this equipment class. Follow the manufacturer's service documentation for the actual procedure.
Where this class of equipment is typically deployed - general reference, not this unit's own placement record.
No documents available for this device yet.
Synced live from the FDA openFDA API.
Some defibrillators serviced between July 2023 through November 2025 were serviced without objective evidence that a Performance Inspection Procedure (PIP) was conducted, and the inability to perform the device's intended use may result in potential harms such as delays or inability to provide therapy.
Incorrect keypad was incorrectly installed onto a defibrillator/monitor.
Product shipped with incorrect IFU. IFU does not include proper cleaning/disinfection instructions
Their is a potential for battery pins to become loose within the defibrillator resulting in power issues.
Packaging of infant child reduced energy electrodes was not properly sealed.
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.
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.
LIFEPAK CR Plus or LIFEPAK Express Automated External Defibrillators (AEDs) are recalled due to the potential to experience an early internal battery depletion issue.
Sterilization efficacy can not be confirmed for the current methods of sterilization listed in the product labeling.
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
The device may not power on although it indicates it is ready for use and would not be able to provide defibrillation therapy.
Describe a symptom or error code. Bio answers from this device's own documented error codes, failure modes, parts, and guides.
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