BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR

    MDR report key: 3970526 · Received July 31, 2014

    Report

    Report Number
    3015876-2014-00875
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    July 3, 2014
    Report Date
    July 3, 2014
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K103567
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE. PHYSIO REPLACED THE QUIK-COMBO THERAPY CABLE ASSEMBLY AND OBSERVED PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS THEN RETURNED TO THE CUSTOMER FOR USE. THE REMOVED DEFIBRILLATION THERAPY CABLE ASSEMBLY WAS FURTHER EVALUATED IN THE FAILURE ANALYSIS CENTER AND THE CAUSE OF THE REPORTED FAILURE WAS DETERMINED TO DUE TO THE STERNUM WIRE BEING OPEN AT THE CONNECTOR STRAIN RELIEF.

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE. PHYSIO REPLACED THE QUIK-COMBO THERAPY CABLE ASSEMBLY AND OBSERVED PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS THEN RETURNED TO THE CUSTOMER FOR USE. THE REMOVED DEFIBRILLATION THERAPY CABLE ASSEMBLY WAS FURTHER EVALUATED IN THE FAILURE ANALYSIS CENTER AND THE CAUSE OF THE REPORTED FAILURE WAS DETERMINED TO DUE TO THE STERNUM WIRE BEING OPEN AT THE CONNECTOR STRAIN RELIEF. THE INITIAL MEDWATCH REPORT SHOULD INDICATE: PHYSIO-CONTROL REPLACED THE QUIK-COMBO THERAPY CABLE ASSEMBLY FOR THE CUSTOMER. THE REMOVED QUIK-COMBO THERAPY CABLE ASSEMBLY WAS RETURNED TO PHYSIO-CONTROL AND FURTHER EVALUATED IN THE FAILURE ANALYSIS CENTER. THE CAUSE OF THE REPORTED FAILURE WAS DETERMINED TO DUE TO THE STERNUM WIRE BEING OPEN AT THE CONNECTOR STRAIN RELIEF. THE DEVICE ITSELF WAS NOT RETURNED TO PHYSIO-CONTROL FOR EVALUATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEIR DEVICE WOULD NOT DETECT THE DEFIBRILLATION THERAPY CABLE ASSEMBLY. THIS WAS DETECTED DURING A DAILY DEVICE CHECK AND WAS NOT ASSOCIATED WITH PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448165 LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC 15

    Patients

    Seq Age Sex Outcome Treatment
    1