BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK CR PLUS DEFIBRILLATOR

    MDR report key: 2151367 · Received June 8, 2011

    Report

    Report Number
    3015876-2011-00455
    Event Type
    Malfunction
    Date Received
    June 8, 2011
    Date of Event
    March 22, 2011
    Report Date
    May 11, 2011
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K011144
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL FURTHER EVALUATED THE DEVICE AND DETERMINED THAT THE CAUSE OF THE FAILURE WAS DUE TO A FAILURE OF A BATTERY, DESIGNATOR BT1 ON THE ANALOG PCB ASSEMBLY. THE LOW CAPACITY OF THIS BATTERY CAUSED THE DEVICE TO NOT HAVE THE ABILITY OF DELIVERING ANY MORE THAN THREE (3) DEFIBRILLATION SHOCKS. THE CUSTOMER RECEIVED A REPLACEMENT DEVICE.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE DEVICE HAD AN ILLUMINATED CHARGE-PAK ICON AFTER SEVERAL ATTEMPTS AT REPLACING THE CHARGE-PAK ASSEMBLY. THE CUSTOMER WAS SENT A REPLACEMENT DEVICE UNDER WARRANTY. AFTER INITIAL EVALUATION OF THE DEVICE, IT WAS OBSERVED THAT THE DEVICE DID NOT HAVE ENOUGH BATTERY CAPACITY TO DELIVER ANY MORE THAN THREE (3) DEFIBRILLATION SHOCKS, IF NEEDED. THERE WAS NO PT USE ASSOCIATED WITH THE REPORTED FAILURE.

    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