BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 15 MONITOR/DEFIBRILLATOR

    MDR report key: 1770113 · Received July 21, 2010

    Report

    Report Number
    3015876-2010-00842
    Event Type
    Malfunction
    Date Received
    July 21, 2010
    Date of Event
    June 23, 2010
    Report Date
    June 23, 2010
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K082937
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4): PHYSIO-CONTROL EVALUATED THE DEVICE AND OBSERVED AN INTERMITTENT POWER FAILURE. PHYSIO DETERMINED THE CAUSE OF THE FAILURE TO BE THE (B) (4) USB CABLE. PHYSIO REPLACED THE USB CABLE FROM THE CUSTOMER STOCK AND COMPLETED OTHER UNRELATED REPAIRS. PROPER DEVICE OPERATION WAS CONFIRMED THROUGH FUNCTIONAL AND PERFORMANCE TESTING BEFORE IT WAS RETURNED TO THE CUSTOMER FOR USE. FURTHER EVALUATION OF THE REMOVED USB CABLE AT THE FAILURE ANALYSIS CENTER FOUND IT INTERMITTENTLY CAUSING A TEST MOCK-UP DEVICE TO LOSE POWER AND/OR INHIBIT IT FROM POWERING ON WHILE CONNECTED. FURTHER CAUSE FOR THE CABLE FAILURE WAS AN ELECTRICAL SHORT.

    Description of Event or Problem · 1

    DURING A PATIENT USE, IT WAS REPORTED THAT THE DEVICE WOULD NOT COMPLETE THE BOOT UP CYCLE WHILE ATTEMPTING TO POWER ON. HOWEVER, THE REPORTED FAILURE HAD NO ADVERSE EFFECTS ON THE PATIENT.

    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