BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUT EXT DR FINAL ASSY-REVERSE

    MDR report key: 1790312 · Received August 5, 2010

    Report

    Report Number
    1518293-2010-00096
    Event Type
    Malfunction
    Date Received
    August 5, 2010
    Date of Event
    July 9, 2010
    Report Date
    July 9, 2010
    Manufacturer
    LIEBEL-FLARSHEIM CO.
    Product Code
    KQS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FIELD SERVICE ENGINEER INVESTIGATED ERROR, BUT COULD NOT DUPLICATE THE PROBLEM. FSE TALKED TO LF TECH SUPPORT WHO SUGGESTED REPLACING THE CAMERA SINCE THE CUSTOMER REPORTED THE PROBLEM HAD OCCURRED MORE THAN ONCE ON THIS NEW INSTALL. FSE REPLACED THE CAMERA AND CHECKED OPERATION ACCORDING TO CHECKLIST (B)(4) UNIT PASSED CHECKOUT PROCEDURES, SYSTEM RETURNED TO FULL SERVICE BY THE CUSTOMER.

    Description of Event or Problem · 1

    ON 7/29: CUSTOMER REPORTS DURING PROCEDURE, THE SYSTEM FAILED. STAFF HAD TO REBOOT THE SYSTEM SEVERAL TIMES BEFORE THE CAMERA WAS DETECTED AND PROCEDURE COULD BE COMPLETED. CUSTOMER PROVIDES NO PROCEDURAL OR PATIENT INFORMATION OTHER THAN TO SAY PROCEDURE COMPLETED WITH NO REPORTED INJURY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK