BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 20 DEFIBRILLATOR/MONITOR

    MDR report key: 1960759 · Received December 16, 2010

    Report

    Report Number
    3015876-2010-01375
    Event Type
    Malfunction
    Date Received
    December 16, 2010
    Date of Event
    November 17, 2010
    Report Date
    November 17, 2010
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    LDD
    PMA / PMN Number
    K012274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): PHYSIO CONTROL CONTINUES TO INVESTIGATE THE REPORTED EVENT AND WILL SUBMIT A SUPPLEMENTAL REPORT ON THIS EVENT TO THE FDA AS PROVIDED BY 21 CFR 803.56.

    Description of Event or Problem · 1

    DURING A SCHEDULED INSPECTION, PHYSIO- CONTROL FOUND THAT THE DEVICE WOULD LOCK- UP UPON POWER ON. IT WAS NOT AVAILABLE TO PROVIDE THERAPY IN THE OBSERVED CONDITION. THERE WAS NO PATIENT USE ASSOCIATED WITH THE EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA