BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUT EXT DR FINAL ASSY-REVERSE

    MDR report key: 1162331 · Received September 8, 2008

    Report

    Report Number
    1518293-2008-00268
    Event Type
    Malfunction
    Date Received
    September 8, 2008
    Date of Event
    August 12, 2008
    Manufacturer
    LIEBEL-FLARSHEIM CO
    Product Code
    KQS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PHYSICIST REPORT WAS NOT AVAILABLE FOR FIELD SERVICE ENGINEER TO REVIEW. FIELD SERVICE ENGINEER CHECKED THE DOSAGE PER THE SEDECAL GENERATOR SERVICE MANUAL, AND FOUND THE 10R DOSAGE TO BE 9.5R/MIN AND 5R DOSAGE AT 4.4R/MIN, BOTH WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    PHYSICIST REPORTED THAT THE FLUORO R/MIN RATE WAS 30 PPS AND EXCEEDS 10R/MIN WHEN MAX CONTINUATION IS PLACED IN THE FIELD OF A 2 MM LEAD SHIELD. THIS IS TRUE FOR NORMAL MAG 1,2,3 MODES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUT EXT DR FINAL ASSY-REVERSE HUT EXT KQS LIEBEL-FLARSHEIM CO HUT EXT NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA