BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 15 MONITOR/DEFIBRILLATOR

    MDR report key: 2033393 · Received March 22, 2011

    Report

    Report Number
    3015876-2011-00260
    Event Type
    Malfunction
    Date Received
    March 22, 2011
    Date of Event
    February 17, 2011
    Report Date
    February 21, 2011
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K082937
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE. PHYSIO 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

    IT WAS REPORTED THAT THE DEVICE RANDOMLY LOST POWER APPROXIMATELY FIVE TIMES WHILE MONITORING A PATIENT. THE DEVICE USE HAD NO ADVERSE EFFECTS ON THE PATIENT. THERE WERE NO FURTHER DETAILS ON THE EVENT AND/OR THE PATIENT PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK