BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPHASIC LIFEPAK(R) 500 AUTOMATED EXTERNAL DEFIBRILLATOR

    MDR report key: 2895686 · Received January 3, 2013

    Report

    Report Number
    3015876-2013-00012
    Event Type
    Malfunction
    Date Received
    January 3, 2013
    Date of Event
    December 7, 2012
    Report Date
    December 7, 2012
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K052057
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A PHYSIO-CONTROL SERVICE REPRESENTATIVE EXAMINED THE CUSTOMER'S DEVICE AND VERIFIED THE REPORTED FAILURE. HE THEN REPLACED THE MAIN PCB ASSEMBLY AND AFTER OBSERVING PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING THE UNIT WAS RETURNED TO THE CUSTOMER FOR USE.

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL FURTHER EVALUATED THE REMOVED MAIN PCB ASSEMBLY AND DETERMINED THAT THE CAUSE OF THE REPORTED ISSUE WAS DUE TO A FAILURE OF A RELAY, DESIGNATOR K2.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE HAD A SERVICE INDICATOR PRESENT. UPON INSPECTION OF THE DEVICE, THE PHYSIO-CONTROL SERVICE REPRESENTATIVE OBSERVED THAT THE UNIT WOULD NOT PROVIDE ADEQUATE DEFIBRILLATION THERAPY. THE DEVICE WOULD ONLY DELIVER A MAXIMUM OF 140 JOULES. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2540 BIPHASIC LIFEPAK(R) 500 AUTOMATED EXTERNAL DEFIBRILLATOR DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC

    Patients

    Seq Age Sex Outcome Treatment
    1