BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR

    MDR report key: 5228612 · Received November 16, 2015

    Report

    Report Number
    3015876-2015-01406
    Event Type
    Malfunction
    Date Received
    November 16, 2015
    Date of Event
    October 20, 2015
    Report Date
    November 16, 2015
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K142430
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    QA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED TO PHYSIO-CONTROL FOR EVALUATION. A THIRD-PARTY SERVICE AGENT EVALUATED THE DEVICE AND VERIFIED THE REPORTED ISSUE. PHYSIO-CONTROL CONTINUES TO INVESITGATE THE REPORTED ISSUE AND WILL SUBMIT A SUPPLEMENTAL REPORT ON THIS EVEN TO THE FDA AS PROVIDED BY 21 CFR 803.56.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS EVENTUALLY RETURNED TO PHYSIO-CONTROL FOR EVALUATION. PHYSIO EVALUATED THE DEVICE AND VERIFIED THE REPORTED ISSUE. IT WAS OBSERVED THAT THE INTERNAL POSITIVE BATTERY POST FOR BATTERY 2 HAD A CROSS-THREADED KEPS NUT. WHEN TESTING THE DEVICE, IT WOULD POWER OFF OR REBOOT INTERMITTENTLY WHEN POWERED ON BATTERY 2 AND WHEN THE DEVICE WAS MOVED OR MANIPULATED. PHYSIO DETERMINED THAT THE CAUSE OF THE REPORTED ISSUE WAS DUE TO A CROSS-THREADED KEPS NUT ON THE INTERNAL POSITIVE BATTERY POST FOR BATTERY 2. A REPLACEMENT DEVICE WAS PROVIDED TO THE CUSTOMER UNDER WARRANTY.

    Description of Event or Problem · 1

    IT WAS REPORTED TO PHYSIO-CONTROL THAT THE CUSTOMER'S DEVICE TURNED OFF BY ITSELF INTERMITTENTLY WHEN THE CUSTOMER PUSHED THE SUMMARY BUTTON ON THE DEVICE. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    756744 LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC 15

    Patients

    Seq Age Sex Outcome Treatment
    1