BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK CR(R) PLUS DEFIBRILLATOR

    MDR report key: 3230418 · Received July 16, 2013

    Report

    Report Number
    3015876-2013-00627
    Event Type
    Malfunction
    Date Received
    July 16, 2013
    Date of Event
    June 18, 2013
    Report Date
    June 21, 2013
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K033275
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL FURTHER EVALUATED THE DEVICE AND OBSERVED THAT THE ANALOG PCB ASSEMBLY HAD DRAWN EXCESSIVE CURRENT. PHYSIO-CONTROL FURTHER EVALUATED THE ANALOG PCB ASSEMBLY AND DETERMINED THAT THE CAUSE OF THE REPORTED FAILURE WAS DUE TO A FILTER, DESIGNATOR FL9 ON THE ANALOG PCB ASSEMBLY, LEAKING AT 112 MICRO AMPERE. THIS CAUSED THE INTERNAL HLC BATTERIES TO DEPLETE. A REPLACEMENT DEVICE WAS PROVIDED TO THE CUSTOMER UNDER WARRANTY.

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE. IT WAS OBSERVED THAT THE VOICE PROMPT THAT WAS STARTED UPON OPENING THE DEVICE WAS INTERRUPTED AND THAT THE DEVICE WOULD NOT FUNCTION ANYMORE. PHYSIO-CONTROL CONTINUES TO INVESTIGATE THE REPORTED FAILURE AND WILL SUBMIT A SUPPLEMENTAL REPORT ON THIS EVENT TO THE FDA AS PROVIDED BY 21 CFR 803.56.

    Description of Event or Problem · 1

    IT WAS REPORTED TO A PHYSIO-CONTROL CUSTOMER SERVICE REPRESENTATIVE THAT THE CUSTOMER'S DEVICE SHOWED THE ATTENTION ICON AND THE CHARGE-PAK ICON IN THE READINESS DISPLAY. WHEN THE DEVICE ARRIVED AT PHYSIO-CONTROL AND THE DEVICE'S LID WAS OPENED, THE SERVICE INDICATOR ICON WAS DISPLAYED AS WELL, AND FROM THEN ON, ALL THREE ICONS WERE DISPLAYED. THE VOICE PROMPT THAT WAS STARTED UPON OPENING THE DEVICE WAS INTERRUPTED AND THE DEVICE WOULD NOT FUNCTION ANYMORE. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329882 LIFEPAK CR(R) PLUS DEFIBRILLATOR DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC CRPLUS

    Patients

    Seq Age Sex Outcome Treatment
    1