BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUT EXT DR FINAL ASSY-REVERSE

    MDR report key: 5051004 · Received September 2, 2015

    Report

    Report Number
    1518293-2015-00087
    Event Type
    Malfunction
    Date Received
    September 2, 2015
    Date of Event
    August 27, 2015
    Report Date
    August 27, 2015
    Manufacturer
    LIEBEL FLARSHEIM
    Product Code
    IXR
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    TECH SERVICE TROUBLESHOT WITH BIOMED WHO CALLED REPORTING AN IMAGING SYSTEM MISALIGNED MESSAGE ON THE TABLE. THE IMAGING SYSTEM WOULD NOT MOVE CORRECTLY USING THE HAND SWITCH, IT WAS SAYING THAT THE TRAVEL LIMITS HAD BEEN REACHED. TECH SERVICE HAD BIOMED GO INTO THE SERVICE MODE TO LOOK AT THE HYDRAULIC PARAMETERS FOR THE IMAGE INTENSIFIER AND FOUND THAT THE CURRENT POSITION WAS OUT OF RANGE ((B)(4)). BIOMED TRIED A TRANSDUCER AMP PCB FROM ANOTHER TABLE, THE ISSUE WENT AWAY, AND THE IMAGE SYSTEM WOULD MOVE. THIS INDICATED THE PROBLEM WAS THE IMAGE INTENSIFIER TRANSDUCER AMP PCB. TECH SERVICE GAVE BIOMED THE REPLACEMENT PART NUMBER TO ORDER. A NEW PART WAS SENT TO BIOMED WHO INSTALLED THE BOARD. ON A FOLLOW UP WITH THE CUSTOMER, IT WAS REPORTED THAT THE SYSTEM WAS REPAIRED AND FULLY FUNCTIONAL.

    Description of Event or Problem · 1

    CUSTOMER REPORTS THE FLUORO FAILED WITH A MISALIGNMENT ERROR AT THE END OF THE CASE. THE PHYSICIAN WAS ABLE TO COMPLETE THE CASE WITH ENDOSCOPY. NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582581 HUT EXT DR FINAL ASSY-REVERSE HUT EXT DR IXR LIEBEL FLARSHEIM HUT EXT DR FINAL ASSY-REVERSE

    Patients

    Seq Age Sex Outcome Treatment
    1