BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 15 MONITOR/DEFIBRILLATOR

    MDR report key: 1903189 · Received November 12, 2010

    Report

    Report Number
    3015876-2010-01256
    Event Type
    Malfunction
    Date Received
    November 12, 2010
    Date of Event
    September 16, 2010
    Report Date
    September 16, 2010
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K082937
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL HAS VERIFIED THE REPORTED FAILURE AND CONTINUES TO INVESTIGATE THE PROBLEM. 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 INDICATOR AND LOGGED SEVERAL EVENT CODES IN THE MEMORY. PHYSIO-CONTROL'S SALES REP OBSERVED THE FAILURE AS THE DEVICE WAS PULLED OUT OF THE BOX TO SET UP FOR THE FIRST TIME. THE DEVICE LOCKED UP AND WAS NOT AVAILABLE FOR USE. 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