BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUT EXT DR FINAL ASSY-STANDARD

    MDR report key: 1931297 · Received November 16, 2010

    Report

    Report Number
    1518293-2010-00155
    Event Type
    Malfunction
    Date Received
    November 16, 2010
    Date of Event
    November 2, 2010
    Report Date
    November 2, 2010
    Manufacturer
    LIEBEL-FLARSHEIM CO.
    Product Code
    KQS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FIELD SERVICE ENGINEER CONFIRMED THE UNIT WOULD NOT POWER UP AND FOUND NO VOLTAGE WAS COMING FROM THE 5/+12/-12 VOLT POWER SUPPLY UNIT. FSE TROUBLESHOT AND REPLACED A BLOWN FUSE ON THE POWER SUPPLY. FSE TESTED SYSTEM PER THE HUT DR SERVICE MANUAL, VERIFIED ALL SYSTEM FUNCTIONS WITHIN MFG SPECS. SYSTEM RETURNED TO FULL SERVICE BY THE CUSTOMER.

    Description of Event or Problem · 1

    ON (B)(6) 2005: CUSTOMER REPORTS THE SYSTEM FAILED PRIOR TO PT PROCEDURE. CUSTOMER DOES NOT HAVE A BACK UP ROOM AND PATIENTS HAD TO BE TRANSPORTED TO ANOTHER FACILITY FOR COMPLETION OF PROCEDURES. 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