BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUT EXT DR FINAL ASSY-REVERSE

    MDR report key: 4128579 · Received September 30, 2014

    Report

    Report Number
    1518293-2014-00121
    Event Type
    Malfunction
    Date Received
    September 30, 2014
    Date of Event
    September 5, 2014
    Report Date
    December 4, 2014
    Manufacturer
    LIEBEL FLARSHEIM
    Product Code
    IXR
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    PENDING INVESTIGATION. UPON RECEIPT OF INVESTIGATION, A MEDWATCH 3500A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    TECH SERVICE TROUBLESHOT WITH BIOMED WHO REPORTED THEIR SYSTEM WAS NOT ALLOWING ANY FLUORO OR X-RAY EXPOSURES. THE IMAGE MONITOR DISPLAYS `GIM COMMUNICATION ERROR. TECH SERVICE ADVISED THE GIM (GENERATOR INTERFACE MODULE), WAS NOT FUNCTIONING AND GAVE BIOMED INFORMATION TO DETERMINE THE PROBLEM. IT WAS FOUND THAT THE GIM HAD LOCKED UP AND FAILED. THE SYSTEM WILL NOT ALLOW ANY FLUORO / X-RAY IF THE GIM HAS FAILED. TECH SERVICE GAVE BIOMED THE PART NUMBER FOR A REPLACEMENT GIM, 710260 AS BIOMED WANTED TO REPLACE THIS PART HIMSELF. A FIELD SERVICE ENGINEER (FSE) WAS ON SITE 11/18/2014 AND COMPLETED A STANDARD PREVENTATIVE MAINTENANCE (PM) ON THIS UNIT WITHOUT ANY ISSUES NOTED. THE SYSTEM WAS FULLY FUNCTIONAL AND THE CUSTOMER REPORTED THE REPLACEMENT GIM CORRECTED THE ISSUE.

    Description of Event or Problem · 1

    CUSTOMER REPORTS THE FLUORO FAILED DURING AN UROLOGY PROCEDURE. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED, BUT THE CUSTOMER REPORTS NO INJURY.. NO ADDITIONAL PATIENT DETAILS ARE KNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    609069 HUT EXT DR FINAL ASSY-REVERSE IXR IXR LIEBEL FLARSHEIM HUT EXT DR FINAL ASSY-REVERSE

    Patients

    Seq Age Sex Outcome Treatment
    1