BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 15 MONITOR/DEFIBRILLATOR

    MDR report key: 1901072 · Received November 10, 2010

    Report

    Report Number
    3015876-2010-01242
    Event Type
    Malfunction
    Date Received
    November 10, 2010
    Date of Event
    October 12, 2010
    Report Date
    October 12, 2010
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K082937
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE. THE USB CABLES WERE REPLACED AND THEN PROPER DEVICE OPERATION WAS OBSERVED THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS RETURNED TO THE CUSTOMER FOR USE. PHYSIO-CONTROL FURTHER EVALUATED THE REMOVED CABLES AND OBSERVED THAT THEY HAD SHORTED, CAUSING THE REPORTED FAILURE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT DURING PATIENT USE THE SERVICE LOANER DEVICE POWERED OFF. THEY WERE UNABLE TO POWER IT BACK ON. WHEN THE CREW RETURNED TO THE STATION, THE DEVICE WAS TESTED WITH THE BATTERIES FROM THE CALL AND WAS OBSERVED TO FAIL 10 TIMES IN A ROW. THE LIGHTS WOULD FLICKER ONLY. AFTER THAT, THE DEVICE OPERATED PROPERLY. IT WAS INDICATED THAT THE CUSTOMER WAS JUST MONITORING THE PATIENT AND THERE WAS NO COMPROMISE TO THEIR CARE OR ADVERSE EVENT AS A RESULT OF THE REPORTED FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEPAK 15 MONITOR/DEFIBRILLATOR MKJ PHYSIO-CONTROL, INC. 15 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK