BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 15 MONITOR/DEFIBRILLATOR

    MDR report key: 1982397 · Received January 14, 2011

    Report

    Report Number
    3015876-2011-00048
    Event Type
    Malfunction
    Date Received
    January 14, 2011
    Date of Event
    December 17, 2010
    Report Date
    December 17, 2010
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K082937
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): PHYSIO-CONTROL EVALUATED THE DEVICE AND FOUND THAT IT WOULD NOT POWER ON AC OR DC POWER. PHYSIO IS IN THE PROCESS OF EVALUATING/REPAIRING THE DEVICE. PHYSIO 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 DAILY TEST, IT WAS REPORTED THAT THE DEVICE WOULD NOT POWER OFF WHEN THE POWER BUTTON WAS PRESSED QUICKLY. FURTHERMORE, THE DEVICE WOULD NOT POWER BACK ON IMMEDIATELY AFTER POWERING OFF AND THERE WAS A DELAY. THERE WAS NO PATIENT 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