BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES

    MDR report key: 1972629 · Received January 19, 2011

    Report

    Report Number
    3015876-2011-00061
    Event Type
    Malfunction
    Date Received
    January 19, 2011
    Date of Event
    December 23, 2010
    Report Date
    December 23, 2010
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K991910
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL EVALUATED THE DEVICE AND WAS UNABLE TO VERIFY OR DUPLICATE THE REPORTED FAILURE. PHYSIO OBSERVED PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS THEN RETURNED TO THE CUSTOMER FOR USE. A CONCLUSIVE CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE LOST POWER WHILE MONITORING A PT ON A CARDIAC ARREST CALL. THE HEALTH PROFESSIONAL AT THE SCENE INFORMED THAT THE DEVICE USE HAD NO ADVERSE EFFECTS ON THE PT AS AN ASYSTOLE ECG RHYTHM WAS ASSESSED INITIALLY AND IT REMAINED THROUGHOUT THE CALL. DEFIBRILLATION THERAPY WAS NOT REQUIRED DURING THE EVENT. THE PT WAS NOT REVIVED. 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