BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES

    MDR report key: 1983317 · Received February 4, 2011

    Report

    Report Number
    3015876-2011-00113
    Event Type
    Malfunction
    Date Received
    February 4, 2011
    Date of Event
    January 6, 2011
    Report Date
    January 6, 2011
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K991910
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): PHYSIO-CONTROL EVALUATED THE DEVICE; HOWEVER THE REPORTED FAILURE WAS NOT DUPLICATED. PHYSIO-CONTROL IS IN THE PROCESS OF EVALUATING THE DEVICE 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 POWERED ITSELF OFF AND ON DURING PATIENT USE. IT WAS REPORTED THAT THE FAILURE DID NOT HAVE ANY ADVERSE EFFECTS ON THE PATIENT. THERE WAS NO OTHER INFORMATION REGARDING THE EVENT OR THE PATIENT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES MKJ PHYSIO-CONTROL, INC NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK