BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUT EXT DR FINAL ASSY-STANDARD

    MDR report key: 3193162 · Received June 25, 2013

    Report

    Report Number
    1518293-2013-00140
    Event Type
    Malfunction
    Date Received
    June 25, 2013
    Date of Event
    June 11, 2013
    Report Date
    June 25, 2013
    Manufacturer
    LIEBEL-FLARSHEIM CO.
    Product Code
    IXR
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FIELD SERVICE ENGINEER (FSE) INVESTIGATED AND FOUND THERE WAS NO COLLIMATOR POWER AND THERE WAS A GENERATOR NOT COMMUNICATING MESSAGE FAULT ON THE CONSOLE. FSE TROUBLESHOT FUSES WHICH WERE GOOD AND TURNED ON THE GENERATOR TAKING CARE TO HOLD THE ON SWITCH FOR A FEW SECONDS. THE UNIT CAME ON AND WORKED PROPERLY. FSE CYCLED POWER SEVERAL TIMES AND CHECKING OPERATION ACCORDING TO CHECKLIST (B)(4) THE HUT SERVICE MANUALS. UNIT PASSED CHECKOUT PROCEDURES AND WAS RETURNED TO CUSTOMER FOR SERVICE.

    Description of Event or Problem · 1

    ON (B)(6): CUSTOMER REPORTS VIA PHONE THAT THE SYSTEM FLUORO FAILED WHEN STARTING FOR DAYS PROCEDURES. CUSTOMER DOES NOT HAVE A BACKUP ROOM, AND PT URODYNAMIC PROCEDURES WERE CANCELLED. NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288183 HUT EXT DR FINAL ASSY-STANDARD IXR LIEBEL-FLARSHEIM CO. HUT EXT DR NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK