BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUT EXT DR FINAL ASSY-STANDARD

    MDR report key: 2922010 · Received January 15, 2013

    Report

    Report Number
    1518293-2013-00015
    Event Type
    Malfunction
    Date Received
    January 15, 2013
    Date of Event
    January 10, 2013
    Report Date
    January 15, 2013
    Manufacturer
    LIEBEL-FLARSHEIM CO.
    Product Code
    IXR
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FIELD SERVICE ENGINEER (FSE) TROUBLESHOOT THE SYSTEM AND FOUND WHEN PRESSING THE POWER BUTTON ON THE GENERATOR CONSOLE, A RELAY IN THE GENERATOR WOULD CLICK AND FANS WOULD COME ON, BUT WHEN LETTING OFF THE BUTTON, THE SYSTEM WOULD TURN BACK OFF. FSE REPLACED GENERATOR CONSOLE AND VERIFIED PROPER OPERATION PER SEDECAL SERVICE MANUAL. FSE THEN COMPLETED THE MINOR GENERATOR PORTION OF THE HYDRAVISION DR SYSTEM CHECKLIST (B)(4), PER HUT SERVICE MANUAL AND RETURNED THE UNIT TO SERVICE.

    Description of Event or Problem · 1

    ON (B)(6) 2013, CUSTOMER STATES VIA PHONE THAT DURING A CYSTOSCOPY PROCEDURE ON A FEMALE PT OF UNKNOWN AGE THE HUT SYSTEM SHUT DOWN AND WOULD NOT POWER BACK UP. THE PHYSICIAN FINISHED THE PROCEDURE VISUALLY. NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22980 HUT EXT DR FINAL ASSY-STANDARD IXR LIEBEL-FLARSHEIM CO. HUT EXT DR NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK