BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPHASIC LIFEPAK(R) 500 AUTOMATED EXTERNAL DEFIBRILLATOR

    MDR report key: 2883260 · Received December 21, 2012

    Report

    Report Number
    3015876-2012-00934
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Date of Event
    November 27, 2012
    Report Date
    November 27, 2012
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K052057
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): PHYSIO-CONTROL HAS EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE. 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. (B)(4): PHYSIO-CONTROL HAS EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE. PHYSIO REMOVED THE MAIN PCB ASSEMBLY FOR FURTHER EVALUATION. 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. PHYSIO-CONTROL FURTHER EVALUATED THE REMOVED MAIN PCB ASSEMBLY AND DETERMINED THAT THE CAUSE OF THE REPORTED FAILURE WAS DUE TO A FAILURE OF AN INTEGRATED CIRCUIT, DESIGNATOR U17. THE CUSTOMER DECIDED NOT TO PROCEED WITH THE REPAIR OF THE DEVICE DUE TO COSTS ASSOCIATED WITH THE REPAIR, AND REQUESTED THAT THE DEVICE BE DISCARDED.

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL HAS EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE. 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

    IT WAS REPORTED THAT THE DEVICE'S BATTERY WARNING AND SERVICE INDICATOR WERE LIT. FURTHER TO EVALUATION, IT WAS OBSERVED THAT THE DEVICE WOULD NOT OPERATE EVEN WITH A NEW BATTERY INSTALLED; THEREFORE IT WOULD NOT PROVIDE DEFIBRILLATION THERAPY. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1