BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUT EXT DR FINAL ASSY-RECERSE

    MDR report key: 3802648 · Received February 25, 2014

    Report

    Report Number
    1518293-2014-00023
    Event Type
    Malfunction
    Date Received
    February 25, 2014
    Date of Event
    February 18, 2014
    Report Date
    February 18, 2014
    Manufacturer
    LIEBEL FLARSHEIM
    Product Code
    IXR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) TECH SUPPORT (TS) TROUBLESHOT WITH BIOMED A REPORT OF 'NO CAMERA DETECTED' THAT OCCURRED DURING A PROCEDURE. TECH SUPPORT EXPLAINED THE VARIOUS THINGS HE COULD CHECK THAT COULD HAVE CAUSED THIS ERROR MESSAGE; THE CAMERA, IAPDB BOARD, LVDS INTERFACE BOARD OR IT COULD BE DUE TO CABLE CONNECTIONS. ON 02/19/2014 MALLINCKRODT PRODUCT MONITORING FOLLOWED UP WITH THE CUSTOMER WHO REPORTED THEY HAD RESEATED THE LVDS BOARD, AND AFTER RESTARTING, THE SYSTEM HAS FUNCTIONED FINE WITH NO REPORTED PROBLEMS.

    Description of Event or Problem · 1

    CUSTOMER REPORTS VIA PHONE THAT DURING AN UNDETERMINED UROLOGY PROCEDURE THE STAFF LOST THE FLUORO IMAGE. PHYSICIAN COMPLETED THE PROCEDURE USING ONLY ENDOSCOPY. CUSTOMER PROVIDED NO FURTHER PATIENT OR PROCEDURAL INFORMATION OTHER THAN TO SAY THE PATIENT IS FINE. NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116233 HUT EXT DR FINAL ASSY-RECERSE IXR LIEBEL FLARSHEIM HUT EXT DR FINAL A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK