BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR

    MDR report key: 3953671 · Received July 23, 2014

    Report

    Report Number
    3015876-2014-00843
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Date of Event
    June 23, 2014
    Report Date
    June 25, 2014
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K103567
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL MEDWATCH REPORT INDICATES : APPROXIMATE AGE OF DEVICE - 9 YEARS. THE INITIAL MEDWATCH REPORT SHOULD INDICATE: APPROXIMATE AGE OF DEVICE - 4 YEARS. THE INITIAL MEDWATCH REPORT INDICATES: DEVICE MANUFACTURE DATE -(B)(4) 2005. THE INITIAL MEDWATCH REPORT SHOULD INDICATE: DEVICE MANUFACTURE DATE - (B)(4) 2010.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEIR DEVICE WAS LOSING POWER AFTER A FEW SECONDS OF BEING POWERED ON. THERE WAS NO REPORT OF ANY PATIENT USE ASSOCIATED WITH THE REPORTED FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430149 LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC 15

    Patients

    Seq Age Sex Outcome Treatment
    1