BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK CR PLUS DEFIBRILLATOR

    MDR report key: 1901074 · Received November 10, 2010

    Report

    Report Number
    3015876-2010-01240
    Event Type
    Malfunction
    Date Received
    November 10, 2010
    Date of Event
    October 12, 2010
    Report Date
    October 12, 2010
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K011144
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE TWO INSTALLED BATTERY CHARGERS WERE RETURNED TO PHYSIO-CONTROL FOR EVALUATION. THERE WAS NO FAILURES FOUND WITH BOTH CHARGERS. PHYSIO IS ANTICIPATING THE DEVICE RETURN TO THE MANUFACTURING FACILITY AND CONTINUES TO INVESTIGATE THE REPORTED EVENT. PHYSIO-CONTROL 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 THAT THE DEVICE CONTINUED TO DISPLAY THE CHARGE PAK AND LOW BATTERY INDICATORS WHEN TWO INTERNAL BATTERY CHARGERS WERE INSTALLED. THE DEVICE DOWNLOAD REVIEW SHOWED THAT THE INTERNAL HLC BATTERIES WERE CHARGE DEPLETED TO A CRITICAL LEVEL PRIOR TO REPLACEMENT OF THE BATTERY CHARGERS. THE DEVICE WAS NOT ABLE TO PROVIDE DEFIBRILLATION THERAPY IN THE REPORTED CONDITION. THERE WAS NO PATIENT USE ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEPAK CR PLUS DEFIBRILLATOR MKJ PHYSIO-CONTROL, INC. CRPLUS NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA