BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR

    MDR report key: 3910190 · Received July 2, 2014

    Report

    Report Number
    3015876-2014-00757
    Event Type
    Malfunction
    Date Received
    July 2, 2014
    Date of Event
    June 5, 2014
    Report Date
    June 5, 2014
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K103567
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL EXAMINED THE DEVICE AND VERIFIED THE REPORTED ISSUE. PHYSIO OBSERVED THAT THE BIPHASIC TO THERAPY PCB CABLE WAS NOT CORRECTLY SEATED TO THE THERAPY PCB ASSEMBLY. THIS ISSUE PREVENTED ENERGY DEFIBRILLATION FROM BEING DELIVERED. PHYSIO RESEATED THE CONNECTION AND AFTER OBSERVING PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING THE UNIT WAS RETURNED TO THE CUSTOMER FOR USE.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE HAD FAILED A USER TEST. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT. UPON EVALUATION OF THE DEVICE PHYSIO OBSERVED THAT THE DEVICE WOULD NOT DEFIBRILLATE. INSTEAD, AN "ABNORMAL ENERGY DELIVERED" MESSAGE WOULD APPEAR ON THE DISPLAY AND THE DEFIBRILLATION OUTPUT WAS ZERO (0) JOULES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386470 LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC 15

    Patients

    Seq Age Sex Outcome Treatment
    1