BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES

    MDR report key: 2133242 · Received May 11, 2011

    Report

    Report Number
    3015876-2011-00376
    Event Type
    Malfunction
    Date Received
    May 11, 2011
    Date of Event
    April 12, 2011
    Report Date
    April 12, 2011
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K991910
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE. PHYSIO IS IN THE PROCESS OF REPAIRING THE DEVICE AND CONTINUES TO INVESTIGATE THE REPORTED EVENT. PHYSIO-CONTROL WILL SUBMIT A SUPPLEMENTAL REPORT ON THIS EVENT TO THE FDA.

    Description of Event or Problem · 1

    DURING A PT USE, IT WAS REPORTED THAT THE DEVICE LOST POWER AS THE USER ATTEMPTED TO TAKE BLOOD PRESSURE READING. THEREAFTER, THE DEVICE FAILED TO POWER ON WITH NEW BATTERIES. THERE WAS NO ADVERSE EVENT REPORTED AS THE RESULT OF THE DEVICE USE. THERE WERE NO FURTHER DETAILS ON THE EVENT AND/OR THE PT 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