BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPHASIC LIFEPAK(R) 500 AUTOMATED EXTERNAL DEFIBRILLATOR

    MDR report key: 2802780 · Received October 24, 2012

    Report

    Report Number
    3015876-2012-00792
    Event Type
    Malfunction
    Date Received
    October 24, 2012
    Date of Event
    September 27, 2012
    Report Date
    September 27, 2012
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K052057
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL FURTHER EVALUATED THE REMOVED MAIN PCB ASSEMBLY AT THE FAILURE ANALYSIS CENTER AND DETERMINED THE CAUSE FOR THE MALFUNCTION TO BE DUE TO NUMEROUS TIN WHISKERS ON THE MAIN PCB ASSEMBLY AND THE SHIELD.

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE. PHYSIO REPLACED THE MAIN PCB ASSEMBLY AND OBSERVED PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS THEN RETURNED TO THE CUSTOMER FOR USE.

    Description of Event or Problem · 1

    I WAS REPORTED THAT THE DEVICE FAILED TO POWER ON WHEN A NEW BATTERY WAS INSERTED. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED FAILURE.

    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