BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUT EXT DR FINAL ASSY-REVERSE

    MDR report key: 3130147 · Received May 21, 2013

    Report

    Report Number
    1518293-2013-00099
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Date of Event
    April 29, 2013
    Report Date
    May 21, 2013
    Manufacturer
    LIEBEL-FLARSHEIM CO.
    Product Code
    IXR
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FIELD SERVICE ENGINEER (FSE) TROUBLESHOT ALARM 'NO CAMERA DETECTED' AND FOUND A DEFECTIVE CAMERA CABLE RUNNING THROUGH THE TABLE. FSE REPLACED THE CABLE AND TESTED SYSTEM. DURING SYSTEM CHECKOUT, FSE FOUND THAT THE COLLIMATOR LAMP NOT WORKING AND WAS UNABLE TO CLOSE COLLIMATOR BLADES MANUALLY. CUSTOMER DECLINED COLLIMATOR REPLACEMENT SAYING THAT THEIR GE SERVICE REPRESENTATIVE WILL REPLACE AND VERIFY OPERATION. FSE DID NOT COMPLETE SERVICE CHECKLIST QSSRWI4.1 AND RETURNED TABLE TO CUSTOMER WITH LIMITED USE. (B)(6): CUSTOMER REPORTS THAT GE SERVICE HAS NOT REPAIRED THE COLLIMATOR SYSTEM AS OF THIS DATE. CUSTOMER DOES NOT KNOW WHEN GE SERVICE PLANS TO REPAIR THIS COMPONENT. SYSTEM IS CURRENTLY BEING USED.

    Description of Event or Problem · 1

    (B)(6) 2013: CUSTOMER REPORTS VIA PHONE THAT DURING AN UNKNOWN UROLOGY PROCEDURE (PATIENT AGE AND GENDER CANNOT BE RECALLED) THE ERROR - NO CAMERA DETECTED APPEARED. THE STAFF WAS UNABLE TO FLUORO. TO COMPLETE THE PROCEDURE, THE STAFF MOVED THE PATIENT TO A DIFFERENT TABLE AND USED A PORTABLE FLUORO C-ARM. NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225550 HUT EXT DR FINAL ASSY-REVERSE IXR LIEBEL-FLARSHEIM CO. HUT EXT DR NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK