BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OVERHEAD COUNTERPOISE SYSTEM

    MDR report key: 199160 · Received November 23, 1998

    Report

    Report Number
    2520313-1998-00042
    Event Type
    Malfunction
    Date Received
    November 23, 1998
    Date of Event
    August 4, 1998
    Report Date
    August 12, 1998
    Manufacturer
    F. WALTER HANEL GMBH
    Product Code
    IZI
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    HOSPITAL REPORTED THAT THE OCS FELL. THE YOKE BROKE. NO ONE INJURED. HOSPITAL STATED THEY MOUNTED THE HEAD ON A FLOOR STAND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OVERHEAD COUNTERPOISE SYSTEM OVERHEAD COUNTERPOISE SYSTEM IZI F. WALTER HANEL GMBH 0CS115 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other