BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK CR(R) PLUS DEFIBRILLATOR

    MDR report key: 4122986 · Received September 26, 2014

    Report

    Report Number
    3015876-2014-01138
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    September 4, 2014
    Report Date
    September 4, 2014
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K033275
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL EVALUATED THE CUSTOMER'S DEVICE AND VERIFIED THE REPORTED ISSUE. PHYSIO OBSERVED THAT THE CUSTOMER HAD PREVIOUSLY INSTALLED THE SHORTING PLUG ONTO THE DEVICE'S CHARGE PAK ASSEMBLY AND THEN REMOVED IT. THIS ACTION OF INSTALLING AND REMOVING THE SHORTING PLUG CRUSHED THE CONTACTS ON THE CHARGE PAK ASSEMBLY AND, AS A RESULT, IT DRAINED THE INTERNAL HYBRID LAYER CAPACITOR (HLC) BATTERIES WHICH PREVENTED THE DEVICE FROM POWERING ON. THE CAUSE OF THE REPORTED ISSUE WAS DEPLETED INTERNAL HLC BATTERIES; HOWEVER, IT WAS ULTIMATELY A USE ERROR WHICH LED TO THE DEPLETION OF THE INTERNAL HLC BATTERIES.

    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.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE HAD ALL THREE ICONS (CHARGE PAK, ATTENTION AND SERVICE WRENCH) PRESENT ON THE DISPLAY AND WILL NO LONGER POWER ON. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600537 LIFEPAK CR(R) PLUS DEFIBRILLATOR DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC CRPLUS

    Patients

    Seq Age Sex Outcome Treatment
    1