BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK CR(R) PLUS DEFIBRILLATOR

    MDR report key: 4143618 · Received October 6, 2014

    Report

    Report Number
    3015876-2014-01168
    Event Type
    Malfunction
    Date Received
    October 6, 2014
    Date of Event
    June 16, 2014
    Report Date
    September 10, 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

    (B)(4): PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE. IT OBSERVED THAT THE DEVICE DISPLAYED THE CHARGE-PAK AND ATTENTION ICONS. PHYSIO-CONTROL DETERMINED THAT THE CAUSE OF THE REPORTED FAILURE WAS DUE TO AN ELECTRICALLY LEAKY FILTER, DESIGNATOR FL9 ON THE ANALOG PCB ASSEMBLY. THE LEAKY FILTER DEPLETED THE INTERNAL HYBRID LAYER CAPACITOR (HLC) BATTERIES. THE CUSTOMER RECEIVED A REPLACEMENT DEVICE.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE DISPLAYED THE ATTENTION ICON AND INTERMITTENTLY THE WRENCH ICON WOULD DISPLAY. THERE WAS NO PATIENT USE ASSOCIATED WITH THIS EVENT.UPON FURTHER EVALUATION OF THE DEVICE, PHYSIO-CONTROL OBSERVED INTERNAL ELECTRICAL LEAKAGE THAT COULD DEPLETE THE INTERNAL HYBRID LAYER CAPACITOR (HLC) BATTERIES; DEFIBRILLATION THERAPY MAY NOT BE AVAILABLE IF NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    624354 LIFEPAK CR(R) PLUS DEFIBRILLATOR DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC CRPLUS

    Patients

    Seq Age Sex Outcome Treatment
    1