BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUT EXT DR FINAL ASSY-REVERSE

    MDR report key: 2102922 · Received May 4, 2011

    Report

    Report Number
    1518293-2011-00086
    Event Type
    Malfunction
    Date Received
    May 4, 2011
    Date of Event
    April 20, 2011
    Report Date
    April 20, 2011
    Manufacturer
    LIEBEL-FLARSHEIM CO.
    Product Code
    KQS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COVIDIEN PRODUCT MONITORING CONTACTED CUSTOMER AND WAS TOLD THE STAFF DID NOT REALIZE THEY HAD NOT SET COMPUTER SETTINGS CORRECTLY TO ALLOW FOR FLUORO AND RAD IMAGING. THE CUSTOMER MOVED PT TO ANOTHER ROOM PRIOR TO TROUBLESHOOTING ISSUE AND REALIZING THEIR ERROR. STAFF CANCELLED SERVICE CALLS WHEN THEY FOUND THEIR MISTAKE IN COMPUTER SET UP. CUSTOMER RESET THE SYSTEM PROPERLY AND ALL IS FUNCTIONING CORRECTLY. NO REPORTED PROBLEMS WITH EQUIPMENT.

    Description of Event or Problem · 1

    ON (B)(6): CUSTOMER REPORTS THAT A PT WAS HAVING AN UNK UROLOGY PROCEDURE WHEN FLUORO FAILED. STAFF DID NOT PROVIDE INFO OTHER THAN TO REPORT THE PT WAS MOVED TO ANOTHER ROOM, WHERE PROCEDURE WAS COMPLETED WITHOUT INCIDENT AND PT IS DOING 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