BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUT EXT DR FINAL ASSY - STANDARD

    MDR report key: 2240889 · Received August 16, 2011

    Report

    Report Number
    1518293-2011-00134
    Event Type
    Malfunction
    Date Received
    August 16, 2011
    Date of Event
    July 18, 2011
    Report Date
    July 18, 2011
    Manufacturer
    LIEBEL-FLARSHEIM CO.
    Product Code
    KQS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TECH SUPPORT PROVIDED BIOMED WITH THE REPLACEMENT HARD DRIVE PART NUMBER ONLY, AS THE BIOMED WANTED TO ORDER AND INSTALL HIMSELF. A LATER SERVICE CALL WAS OPENED TO ADDRESS A NEW CALL MADE BY THIS BIOMED AFTER INSTALLING THE HARD DRIVE. ON THIS NEW CALL THE BIOMED SAYS THAT HE SUCCESSFULLY CHANGED THE HARD DRIVE BUT NOW, IMAGES IN THE MAG MODES WERE BLACK. FIELD SERVICE ENGINEER CALIBRATED THE GOLD ONE IRIS AND RETURNED THE UNIT TO SERVICE AFTER FSE COMPLETED SERVICE CHECKLIST FOR PROPER OPERATION.

    Description of Event or Problem · 1

    ON (B)(6): CUSTOMER REPORTS THE UROLOGY SUITE COMPUTER WILL NOT BOOT UP. CUSTOMER DOES NOT HAVE A BACK UP ROOM AND UROLOGY PROCEDURES ARE NOT BEING PERFORMED, BUT RESCHEDULED. NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUT EXT DR FINAL ASSY - STANDARD UROLOGY SUITE KQS LIEBEL-FLARSHEIM CO. HUT EXT DR NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK