BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 20 DEFIBRILLATOR/PACEMAKER

    MDR report key: 1060522 · Received June 11, 2008

    Report

    Report Number
    3015876-2008-00592
    Event Type
    Malfunction
    Date Received
    June 11, 2008
    Date of Event
    May 15, 2008
    Report Date
    May 15, 2008
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    LDD
    PMA / PMN Number
    K012274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL REPLACED THE DEVICE, AND WILL EVALUATE IT UPON RETURN FROM CUSTOMER SITE.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, THE DEVICE INTERMITTENTLY LOCKS UP. THERE WAS NO PATIENT ASSOCIATED WITH THE REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEPAK 20 DEFIBRILLATOR/PACEMAKER LDD PHYSIO-CONTROL, INC. 20 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA