BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPHASIC LIFEPAK(R) 500 AUTOMATED EXTERNAL DEFIBRILLATOR

    MDR report key: 3083270 · Received April 29, 2013

    Report

    Report Number
    3015876-2013-00339
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    March 29, 2013
    Report Date
    April 1, 2013
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K052057
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL HAS BEEN UNSUCCESSFUL IN CONTACTING THE CUSTOMER REGARDING THE RESOLUTION OF THE REPORTED DEVICE ISSUE. THE DEVICE HAS NOT BEEN RETURNED TO PHYSIO-CONTROL FOR EVALUATION. THE CAUSE OF THE REPORTED FAILURE COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL CONTINUES TO INVESTIGATE THE REPORTED FAILURE AND WILL SUBMIT A SUPPLEMENTAL REPORT ON THIS EVENT TO THE FDA AS PROVIDED BY 21 CFR 803.56.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A PATIENT EVENT, THEIR DEVICE WOULD NOT RECOGNIZE A CONNECTION TO THE PATIENT AND WOULD CONTINUE TO PROMPT "CONNECT ELECTRODES". THE PATIENT'S CARDIAC ARREST WAS WITNESSED BY THE PATIENT'S WIFE WHERE CPR WAS STARTED IMMEDIATELY. APPROXIMATELY 10 MINUTES LATER, THE FIRE DEPARTMENT EMTS ARRIVED ON SCENE AND CONNECTED THE AED TO THE PATIENT. THIS IS THE TIME WHERE THE DEVICE CONTINUALLY PROMPTED "CONNECT ELECTRODES" AND ALSO GAVE A MOTION DETECTED MESSAGE. THE EMS AMBULANCE ARRIVED APPROXIMATELY 6-7 MINUTES AFTER THE ARRIVAL OF THE FIRE DEPARTMENT AND CONNECTED THEIR DEVICE, WHERE IT WAS OBSERVED THAT THE PATIENT WAS ASYSTOLE. THE PATIENT DID NOT SURVIVE THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184474 BIPHASIC LIFEPAK(R) 500 AUTOMATED EXTERNAL DEFIBRILLATOR DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR