BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUT EXT DR FINAL ASSY-REVERSE

    MDR report key: 1931819 · Received November 30, 2010

    Report

    Report Number
    1518293-2010-00163
    Event Type
    Malfunction
    Date Received
    November 30, 2010
    Date of Event
    November 12, 2010
    Report Date
    November 12, 2010
    Manufacturer
    LIEBEL-FLARSHEIM CO.
    Product Code
    KQS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LIEBEL FLARSHEIM TECH SUPPORT TROUBLESHOT WITH BIOMED AND ADVISED TO FOLLOW THE INFIRMED CAMERA CABLE FROM THE BACK OF THE PLATINUM ONE COMPUTER TOWER TO THE BACK OF THE TABLE, CHECKING ALL CONNECTIONS. ADVISED TO RUN THE TABLE THRU VARIOUS ELEVATION HEIGHTS TO SEE IF THEY CAN REPRODUCE THE ISSUE. PRODUCT MONITORING F/U; BIOMED STATED THE SYSTEM HAS BEEN WORKING CORRECTLY EVER SINCE THE INITIAL REPORTED INCIDENT AND THEY DO NOT PLAN TO CALL IN A LF SVC ENGINEER AT THIS TIME. CUSTOMER CONSIDERS THIS AN ISOLATED EVENT. SYSTEM RETURNED TO FULL SERVICE BY CUSTOMER.

    Description of Event or Problem · 1

    ON 11/22: CUSTOMER REPORTS THE SYSTEM FAILED DURING PT PROCEDURE. PT WAS MOVED TO ANOTHER ROOM, PROCEDURE COMPLETED WITHOUT FURTHER INCIDENT. CUSTOMER PROVIDED NO PT OR PROCEDURAL INFO OTHER THAN TO SAY THE PROCEDURE WAS COMPLETED AND THE PT IS FINE. 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