BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 15 MONITOR/DEFIBRILLATOR

    MDR report key: 2141344 · Received June 1, 2011

    Report

    Report Number
    3015876-2011-00431
    Event Type
    Malfunction
    Date Received
    June 1, 2011
    Date of Event
    April 13, 2011
    Report Date
    May 4, 2011
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K082937
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): PHYSIO-CONTROL IS IN THE PROCESS OF REPAIRING THE DEVICE AND CONTINUES TO INVESTIGATE THE FAILURE. PHYSIO-CONTROL WILL SUBMIT A SUPPLEMENTAL REPORT ON THIS EVENT TO THE FDA AS PROVIDED BY 21 CFR 803.56.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE ILLUMINATED THE SERVICE LED AND LOGGED SEVERAL EVENT CODES IN THE MEMORY. PHYSIO-CONTROL EVALUATED THE DEVICE AND FOUND THAT THE DEVICE WOULD NOT DELIVER CHARGED DEFIBRILLATION THERAPY. THERE WAS NO PT USE ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEPAK 15 MONITOR/DEFIBRILLATOR MKJ PHYSIO-CONTROL, INC 15 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA