BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUT EXT DR FINAL ASSY-STANDARD

    MDR report key: 3881884 · Received May 15, 2014

    Report

    Report Number
    1518293-2014-00055
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Date of Event
    May 5, 2014
    Report Date
    May 5, 2014
    Manufacturer
    LIEBEL-FLARSHEIM COMPANY
    Product Code
    IXR
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FIELD SERVICE ENGINEER (FSE) TROUBLESHOOT THE TABLE MOVEMENT PROBLEM AND FOUND THAT THE TABLE'S 24V POWER SUPPLY HAD A LOW OUTPUT AND REPLACED THE POWER SUPPLY. UNIT WAS CHECKED FOR OPERATION PER SERVICE CHECKLIST AND RETURNED TO FULL SERVICE.

    Description of Event or Problem · 1

    CUSTOMER REPORTS THAT DURING A PROCEDURE THE TABLE MOVEMENT FAILED. STAFF WAS ABLE TO COMPLETE THE PROCEDURE WITHOUT MOVING THE TABLE. NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289637 HUT EXT DR FINAL ASSY-STANDARD IXR LIEBEL-FLARSHEIM COMPANY HUT EXT DR NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK