BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INJECTOR, OPTIVANTAGE DH W/RFID

    MDR report key: 2872042 · Received December 11, 2012

    Report

    Report Number
    1518293-2012-00219
    Event Type
    Malfunction
    Date Received
    December 11, 2012
    Date of Event
    November 13, 2012
    Report Date
    December 11, 2012
    Manufacturer
    LIEBEL-FLARSHEIM CO
    Product Code
    DXT
    PMA / PMN Number
    K042744
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FIELD SERVICE ENGINEER (FSE) ARRIVED ON-SITE AND REPLACED THE J-BOW AND EXTENSION ARM. PROPER OPERATION OF THE INJECTOR WAS VERIFIED PER SERVICE CHECKLIST 844864. LF QA FOLLOWED-UP WITH SERVICE TO DETERMINE THE EXACT LOCATION OF THE BREAK. SERVICE REPORTED THE EXTENSION ARM BROKE AT THE JOINT JUST ABOVE THE J-BOW ARM. THE J-BOW ARM WAS ALSO REPLACED BECAUSE IT COULD NOT BE FREED FROM THE EXTENSION ARM.

    Description of Event or Problem · 1

    ON (B)(6) 2012: CT SUPERVISOR REPORTED VIA PHONE TO LF SERVICE DISPATCH, THAT WHEN HE CAME IN THIS MORNING, THE INJECTOR WAS FOUND IN THIS STATE. THE CEILING SUSPENSION IS BROKEN AND IT IS HANGING FROM A CABLE. UNIT WAS NOT IN USE; NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INJECTOR, OPTIVANTAGE DH W/RFID DXT LIEBEL-FLARSHEIM CO OPTIVANTAGE DH NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NONE