BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INNOVA 2100

    MDR report key: 1111524 · Received August 13, 2008

    Report

    Report Number
    9611343-2008-00040
    Event Type
    Injury
    Date Received
    August 13, 2008
    Date of Event
    April 14, 2008
    Report Date
    August 13, 2008
    Manufacturer
    GE MEDICAL SYSTEMS SCS
    Product Code
    MQB
    PMA / PMN Number
    K052412
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A LONG X-RAY PROCEDURE AND RECEIVED A DOSE HIGHER THAN 30 GRAYS RESULTING IN REDNESS OVER THE BACK. THE SYSTEM PASSED THE TECHNIQUE ACCURACY TEST (KV/MA/DOSE). THERE IS NO EVIDENCE THAT THE SYSTEM IS OUT OF SPECIFICATION. GE HEALTHCARE'S INVESTIGATION INTO THE REPORTED OCCURRENCE IS STILL ONGOING. A FOLLOW-UP REPORT WILL BE ISSUED WHEN THE INVESTIGATION HAS BEEN COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INNOVA 2100 VASCULAR X-RAY SYSTEM MQB GE MEDICAL SYSTEMS SCS

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other