BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 10 DEFIBRILLATOR/MONITOR/PACEMAKER

    MDR report key: 2050094 · Received April 5, 2011

    Report

    Report Number
    3015876-2011-00302
    Event Type
    Malfunction
    Date Received
    April 5, 2011
    Date of Event
    March 8, 2011
    Report Date
    March 8, 2011
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    LDD
    PMA / PMN Number
    K890079
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE CUSTOMER INFORMED PHYSIO-CONTROL THAT THE DEVICE WILL NOT BE REPAIRED AND HAD BEEN REMOVED FROM SERVICE. THE DEVICE WAS NOT RETURNED TO PHYSIO-CONTROL FOR ANALYSIS. THEREFORE, FURTHER INVESTIGATION ON THE REPORTED ISSUE IS NOT POSSIBLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE CAUGHT FIRE AND BURNED A HOLE ON THE RIGHT SIDE OF THE DEVICE BACK SIDE. THE DEVICE WAS NOT IN USE WHEN THE ISSUE OCCURRED AND THE CUSTOMER PUT OUT THE FIRE WITH A FIRE EXTINGUISHER. THERE WAS NO PATIENT 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