BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 10 DEFIBRILLATOR/MONITOR/PACEMAKER

    MDR report key: 1953943 · Received December 16, 2010

    Report

    Report Number
    3015876-2010-01372
    Event Type
    Malfunction
    Date Received
    December 16, 2010
    Date of Event
    November 15, 2010
    Report Date
    November 15, 2010
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    LDD
    PMA / PMN Number
    K890079
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): PHYSIO-CONTROL INFORMED THE CUSTOMER THAT THE DEVICE IS NO LONGER SUPPORTED BY PHYSIO-CONTROL AND REFERRED THE CALLER TO A PART SUPPLIER. F/U WITH THE RPTR FOUND THAT THE CUSTOMER IS CURRENTLY INVESTIGATING REPAIR OPTIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WOULD NOT OPERATE ON AC POWER OR WITH KNOWN GOOD BATTERIES. THERE WAS NO PT USE ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEPAK 10 DEFIBRILLATOR/MONITOR/PACEMAKER LDD PHYSIO-CONTROL, INC 10 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA