BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUT EXT DR FINAL ASSY-REVERSE

    MDR report key: 2052048 · Received March 1, 2011

    Report

    Report Number
    1518293-2011-00029
    Event Type
    Malfunction
    Date Received
    March 1, 2011
    Date of Event
    February 10, 2011
    Report Date
    February 10, 2011
    Manufacturer
    LIEBEL-FLARSHEIM CO.
    Product Code
    KQS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FIELD SERVICE ENGINEER (FSE) FOUND CAMERA WAS NOT WORKING PROPERLY DUE TO THIS IRIS OPENING TOO FAR GIVING AN IMAGE THAT WAS TOO DARK AND GRAINY. FSE REPLACED AND CALIBRATED THE CAMERA PER SERVICE MANUAL AND VERIFIED OPERATION PER SERVICE CHECKLIST. UNIT PASSED CHECKOUT PROCEDURES AND WAS RETURNED TO FULL SERVICE BY CUSTOMER.

    Description of Event or Problem · 1

    (B)(4): CUSTOMER REPORTS THEY LOST FLUORO DURING A PROCEDURE, BUT WOULD NOT PROVIDE PT OR PROCEDURAL INFO OTHER THAN TO SAY 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