BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OVERHEAD COUNTERPOISE SYSTEM

    MDR report key: 284678 · Received June 30, 2000

    Report

    Report Number
    2520313-2000-00004
    Event Type
    Malfunction
    Date Received
    June 30, 2000
    Date of Event
    May 26, 2000
    Report Date
    June 30, 2000
    Manufacturer
    F. WALTER HANEL, GMBH
    Product Code
    DXT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    HOSP REPORTED THE YOKE ASSEMBLY ON THE OVERHEAD COUNTERPOISE SYSTEM BROKE CAUSING THE OCS TO FALL AND HIT THE TECH ON THE SHOULDER. THE TECH SUFFERED SOFT TISSUE DAMAGE AND WAS OFF WORK FOR A COUPLE OF WEEKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OVERHEAD COUNTERPOISE SYSTEM OVERHEAD COUNTERPOISE SYSTEM DXT F. WALTER HANEL, GMBH OCS115 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other