BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 9P DEFIBRILLATOR/MONITOR/PACEMAKER

    MDR report key: 2061855 · Received March 18, 2011

    Report

    Report Number
    3015876-2011-00251
    Event Type
    Malfunction
    Date Received
    March 18, 2011
    Date of Event
    February 16, 2011
    Report Date
    February 16, 2011
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    LDD
    PMA / PMN Number
    K902288
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE. THE CUSTOMER HAS NOT DECIDED IF THEY WILL HAVE THE DEVICE REPAIRED OR SCRAPPED. THE CAUSE OF THE REPORTED FAILURE COULD NOT BE DETERMINED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WOULD NOT CHARGE DEFIBRILLATION ENERGY. THERE WAS NO PT USE ASSOCIATED WITH THE REPORTED FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEPAK 9P DEFIBRILLATOR/MONITOR/PACEMAKER LDD PHYSIO-CONTROL, INC 9P NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA