BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPHASIC LIFEPAK(R) 500 AUTOMATED EXTERNAL DEFIBRILLATOR

    MDR report key: 4875080 · Received June 29, 2015

    Report

    Report Number
    3015876-2015-00731
    Event Type
    Malfunction
    Date Received
    June 29, 2015
    Date of Event
    May 28, 2015
    Report Date
    June 4, 2015
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K052057
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL ADVISED THE CUSTOMER THAT THEIR DEVICE IS NO LONGER UNDER WARRANTY AND NOT FIELD SERVICEABLE BECAUSE IT IS NO LONGER SUPPORTED BY PHYSIO-CONTROL. PHYSIO RECOMMENDED THAT THE UNIT BE PERMANENTLY REMOVED FROM SERVICE AND THAT THE CUSTOMER OBTAIN A REPLACEMENT DEVICE. THE DEVICE HAS NOT BEEN RETURNED TO PHYSIO-CONTROL FOR EVALUATION. THE CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE WOULD NO LONGER POWER ON. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418770 BIPHASIC LIFEPAK(R) 500 AUTOMATED EXTERNAL DEFIBRILLATOR DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC

    Patients

    Seq Age Sex Outcome Treatment
    1