BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK CR(R) PLUS DEFIBRILLATOR

    MDR report key: 3250826 · Received July 29, 2013

    Report

    Report Number
    3015876-2013-00670
    Event Type
    Malfunction
    Date Received
    July 29, 2013
    Date of Event
    July 1, 2013
    Report Date
    July 4, 2013
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K033275
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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.

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE. IT WAS OBSERVED THAT THE DEVICE DID NOT SHOW OK, AND DISPLAYED THE BATTERY, ATTENTION AND SERVICE WRENCH ICONS. IT WAS OBSERVED THAT THE ANALOG PCB ASSEMBLY CAUSED THE DEVICE NOT TO POWER ON. PHYSIO-CONTROL THEN FURTHER EVALUATED THE ANALOG PCB ASSEMBLY AND DETERMINED THAT THE CAUSE OF THE REPORTED FAILURE WAS DUE TO FIELD EFFECT TRANSISTOR, DESIGNATOR Q16 ON THE ANALOG PCB ASSEMBLY CAUSING EXCESS CURRENT. LEG 3 OF THE FIELD EFFECT TRANSISTOR, DESIGNATOR Q16 PULLED THE VOLTAGE DOWN FROM 11 VOLTS TO 9 VOLTS AND CAUSE 124 MA OF OFF CURRENT WHICH DEPLETED THE INTERNAL HLC BATTERIES. A REPLACEMENT DEVICE WAS SENT TO THE CUSTOMER UNDER WARRANTY.

    Description of Event or Problem · 1

    IT WAS REPORTED TO A PHYSIO-CONTROL CUSTOMER SERVICE REPRESENTATIVE THAT THE CUSTOMER'S DEVICE SHOWED ALL THREE ICONS (CHARGE-PAK, SERVICE WRENCH AND ATTENTION) IN THE READINESS DISPLAY AND WOULD NOT POWER ON. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353136 LIFEPAK CR(R) PLUS DEFIBRILLATOR DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC CRPLUS

    Patients

    Seq Age Sex Outcome Treatment
    1