BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK DEFIBRILLATOR/MONITOR

    MDR report key: 1033498 · Received April 23, 2008

    Report

    Report Number
    3015876-2008-00382
    Event Type
    Malfunction
    Date Received
    April 23, 2008
    Date of Event
    March 25, 2008
    Report Date
    March 25, 2008
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    LDD
    PMA / PMN Number
    K012274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL IS CONTINUING TO INVESTIGATE THE REPORTED EVENT.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, THE DEVICE DOES NOT SHOCK WHEN SHOCK BUTTON IS PUSHED AND/OR OPERATES INTERMITTENTLY. THERE WAS NO REPORT OF PT USE ASSOCIATED WITH THE REPORTED EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA