BEUDAMED
    FDA Adverse Event Other Summary report: N

    OMI 7300 OPERATING TABLE

    MDR report key: 456291 · Received April 21, 2003

    Report

    Report Number
    1525725-2003-00020
    Event Type
    Other
    Date Received
    April 21, 2003
    Report Date
    March 20, 2002
    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. OHIO MEDICAL INSTRUMENT CO., INC. HAS ALERTED THE OMI REGIONAL SALES MANAGER WHO WILL CONSEQUENTLY CONTACT THE CUSTOMER TO ALERT THEM OF THE CONDITION AND THAT SOMEONE WILL CALL THE SCHEDULE A TIME FOR A SERVICE GROUP TO PERFORM A INSPECTION OF THE SUSPECT TABLE FOR THE POSSIBLE BURR OR SHARP EDGES ON THE COLUMN COVER AND HOSE DAMAGE. EDGES WILL BE SMOOTHED AND HOSES SECURED. ANY DAMAGED HYDRAULIC HOSE(S) AS A RESULT OF THE BURR OR EDGES WILL BE REMOVED, REPLACED AND SECURED. THE PURPOSE OF THE ATTACHED MEDICAL DEVICE REPORT AND THE CONTENTS OF THIS REPORT ARE TO DOCUMENT AND REPORT THIS EVENT AS A FIELD CORRECTION. THE CUSTOMER(S) WHO HAVE RECEIVED THE SUSPECT TABLES WILL BE CONTACTED AS STATED ABOVE. THE APPROPRIATE ACTION WILL BE TAKEN TO CORRECT THIS UNFORESEEABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMI 7300 OPERATING TABLE OPERATING TABLE GDC OHIO MEDICAL INSTRUMENT CO., INC. 7300-001 *

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other