BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 9 DEFIBRILLATOR/MONITOR

    MDR report key: 1983145 · Received January 31, 2011

    Report

    Report Number
    3015876-2011-00089
    Event Type
    Malfunction
    Date Received
    January 31, 2011
    Date of Event
    January 5, 2011
    Report Date
    January 5, 2011
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    LDD
    PMA / PMN Number
    K881153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE CUSTOMER CONFIRMED THAT THE DEVICE HAS BEEN RETIRED AND TAKEN OUT OF SERVICE. THE DEVICE WILL NOT BE RETURNED TO PHYSIO-CONTROL FOR EVAL. THE CAUSE OF THE REPORTED FAILURE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE HAD A FLASHING SERVICE INDICATOR PRESENT AND IT WAS ALSO GIVING AN ENERGY FAULT MESSAGE WHEN ATTEMPTING TO DELIVER ENERGY. THIS WAS OBSERVED DURING TESTING AND THERE WAS NO PT USE ASSOCIATED WITH THE REPORTED FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEPAK 9 DEFIBRILLATOR/MONITOR LDD PHYSIO-CONTROL, INC. 9 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA