BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES

    MDR report key: 2021988 · Received March 10, 2011

    Report

    Report Number
    3015876-2011-00231
    Event Type
    Malfunction
    Date Received
    March 10, 2011
    Date of Event
    February 11, 2011
    Report Date
    February 11, 2011
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K991910
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED INTERMITTENT FAILURE. THE SYSTEM/MEMORY PCB ASSEMBLY WAS REPLACED AND PROPER DEVICE OPERATION WAS OBSERVED THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS THEN RETURNED TO THE CUSTOMER FOR USE. PHYSIO FURTHER EVALUATED THE REMOVED PCB ASSEMBLY AND DETERMINED THE CAUSE OF THE REPORTED FAILURE TO BE A PCB MOUNTED JACK CONNECTOR, DESIGNATOR J2 THAT WAS NOT SEATED CORRECTLY WHEN SOLDERED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PATIENT INCIDENT, THE DEVICE LOCKED-UP AND WAS NOT FUNCTIONAL, THEN IMMEDIATELY REBOOTED ITSELF. ONCE THE DEVICE POWERED BACK ON, PATIENT CARE WAS CONTINUED UNTIL THE DEVICE LOCKED-UP AND REBOOTED ITSELF A SECOND TIME. FOLLOWING THE SECOND INSTANCE OF THIS FAILURE, THE DEVICE THEN CONTINUED TO FUNCTION NORMALLY THROUGHOUT THE REST OF THE PATIENT INCIDENT. THERE WERE NO ADVERSE EFFECTS CAUSED TO THE PATIENT AS THEY WERE ONLY BEING MONITORED AND DID NOT REQUIRE DEFIBRILLATION THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES MKJ PHYSIO-CONTROL, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR