BEUDAMED
    FDA Adverse Event Other Summary report: N

    OMI 7100 OPERATING TABLE

    MDR report key: 456305 · Received April 21, 2003

    Report

    Report Number
    1525725-2003-00021
    Event Type
    Other
    Date Received
    April 21, 2003
    Report Date
    March 20, 2003
    Manufacturer
    OHIO MEDICAL INSTRUMENT CO., INC.
    Product Code
    GDC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    IN MARCH 2003, OHIO MEDICAL INSTRUMENT CO., INC. (OMI) WAS CONTACTED BY THEIR PARENT COMPANY, SCHAERER MAYFIELD SCHWEIZ AG, AND INFORMED OF A POSSIBLE CONDITION WHICH COULD OCCUR WITH THE MODEL 7100 GENERAL SURGICAL TABLE AND THE 7300 SURGERY TABLE. THE SUSPECT TABLES WERE PRODUCED BY SCHAERER MAYFIELD SCHWEIZ AG BETWEEN FEBRUARY AND OCTOBER 2002. THE COLUMN COVERS MAY HAVE A BURR OR SHARP EDGES THAT COULD POSSIBLY CAUSE DAMAGE TO THE HYDRAULIC HOSE(S). PLEASE NOTE THAT THIS CONDITION HAS BEEN DETERMINED NOT TO BE A PT SAFETY ISSUE BUT COULD POSSIBLY HINDER THE PERFORMANCE OF THE PRODUCT. SCHAERER MAYFIELD SCHWEIZ AG REPORTED THAT FOUR CUSTOMER COMPLAINTS OUTSIDE THE USA HAVE BEEN RECEIVED SINCE DISTRIBUTING THE ABOVE MENTIONED TABLES. SCHAERER MAYFIELD SCHWEIZ AG REPORTED THAT THERE WAS NO PT INJURY AND NO THREAT TO PT SAFETY. OMI HAS NOT RECEIVED ANY CUSTOMER COMPLAINTS TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMI 7100 OPERATING TABLE OPERATING TABLE GDC OHIO MEDICAL INSTRUMENT CO., INC. 7100-001 *

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other