BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUT EXT DR FINAL ASSY-STANDARD

    MDR report key: 1931933 · Received November 30, 2010

    Report

    Report Number
    1518293-2010-00164
    Event Type
    Malfunction
    Date Received
    November 30, 2010
    Date of Event
    November 16, 2010
    Report Date
    November 16, 2010
    Manufacturer
    LIEBEL-FLARSHEIM CO.
    Product Code
    KQS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FIELD SERVICE ENGINEER TROUBLESHOT CUSTOMER COMPLAINT, THE INFIMED COMPUTER WOULD NOT TURN ON. FSE FOUND THE POWER SWITCH ON THE BACK OF INFIMED TOWER WAS OFF. FSE TURNED POWER ON AND THE INFIMED BOOTED UP NORMALLY. OPERATOR ERROR. FSE THEN COMPLETED HUT DR SERVICE CHECKLIST TO VERIFY PROPER FUNCTION. UNIT PASSED ALL TESTS, AND WAS RETURNED TO FULL SERVICE BY THE CUSTOMER.

    Description of Event or Problem · 1

    ON (B)(6): CUSTOMER REPORTS FEMALE HAVING AN UNSPECIFIED TYPE PROCEDURE UNDER GENERAL ANESTHESIA WHEN THE SYSTEM FAILED. STAFF MOVED PT TO ANOTHER ROOM, PROCEDURE COMPLETED WITHOUT FURTHER INCIDENT. PT IS FINE, 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