BEUDAMED
    FDA Adverse Event Other Summary report: N

    9610617-2007-00027

    MDR report key: 933373 · Received October 12, 2007

    Report

    Report Number
    9610617-2007-00027
    Event Type
    Other
    Date Received
    October 12, 2007
    Product Code
    LQS
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    HOSP CONTACT STATED, THAT THIS UNIT HAD BEEN OUT OF SERVICE FOR SOME TIME, BEFORE IT WAS USED IN THIS PROCEDURE. DR USED IT IN A PROCEDURE AFTER THIS INCIDENT AND THERE WERE NO PROBLEMS REPORTED. IT WAS TESTED AFTER THE PROCEDURE BY A BIOTECH, AND AGAIN WAS FOUND TO BE FUNCTIONING WELL. CONTACT STATED THEY NEEDED MORE TRAINING ON THE UNIT; AN IN-SERVICE WAS SCHEDULED AND CARRIED OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LQS

    Patients

    Seq Age Sex Outcome Treatment
    1