BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR

    MDR report key: 5853610 · Received August 8, 2016

    Report

    Report Number
    3015876-2016-00927
    Event Type
    Malfunction
    Date Received
    August 8, 2016
    Date of Event
    July 15, 2016
    Report Date
    August 8, 2016
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K142430
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PMA 510(K): OF THE INITIAL MEDWATCH REPORT INDICATED: 510K - K130456. THE INITIAL MEDWATCH REPORT SHOULD HAVE INDICATED: 510K - K142430

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL EVALUATED THE DEVICE AND WAS UNABLE TO DUPLICATE THE REPORTED ISSUE.  PHYSIO REPLACED THE BATTERY CONNECTOR PINS AS A PRECAUTION AND OBSERVED PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING.  THE DEVICE WAS THEN RETURNED TO THE CUSTOMER FOR USE. THE CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEIR DEVICE WAS LOSING POWER ON A CONSISTENT BASIS. THERE WAS NO REPORT OF ANY PATIENT USE ASSOCIATED WITH THE REPORTED ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    506202 LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC 15

    Patients

    Seq Age Sex Outcome Treatment
    1