BEUDAMED
    FDA Adverse Event Other Summary report: N

    TRAUMEX

    MDR report key: 275289 · Received April 26, 2000

    Report

    Report Number
    MW1018755
    Event Type
    Other
    Date Received
    April 26, 2000
    Date of Event
    April 13, 2000
    Report Date
    April 24, 2000
    Manufacturer
    FISCHER IMAGING CORP.
    Product Code
    IYB
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    DEVICE 1: COLLIMATOR WILL NOT STAY IN ALIGNMENT TO THE FILM RECEPTOR. DEVICE 2: AFTER ROTATING COLLIMATOR, COLLIMATOR WILL NOT STAY IN ALIGNMENT TO THE FILM RECEPTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRAUMEX MEDICAL IMAGING IYB FISCHER IMAGING CORP. 1100-01-002 *
    2 TRAUMEX COLLIMATOR IYO FISCHER IMAGING CORP. COLL-C-150 *

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other