BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OP-TISCH MARS SELECT DS

    MDR report key: 15938199 · Received December 8, 2022

    Report

    Report Number
    3007143268-2022-00030
    Event Type
    Malfunction
    Date Received
    December 8, 2022
    Date of Event
    November 23, 2022
    Report Date
    February 28, 2023
    Manufacturer
    BAXTER MEDICAL SYSTEMS GMBH + CO. KG
    Product Code
    GDC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE OPERATING TABLE MARS SELECT WAS MANUFACTURED IN THE YEAR 2000. NO RECORDS OF REPAIRS OR MAINTENANCE ARE RECORDED WITHIN THE SYSTEM OF THE LEGAL MANUFACTURER. THE DEVICE WILL BE SERVICED BY THE COMPANY SCHNAKENBERG MEDIZIN - & LABORTECHNIK GMBH WHICH IS NOT AN AUTHORIZED SERVICE PARTNER FROM THE LEGAL MANUFACTURER. DURING THE INVESTIGATION IT WAS CONFIRMED BY THE COMPANY SCHNAKENBERG MEDIZIN - & LABORTECHNIK GMBH THAT THE REMOTE CONTROL DID FALL DOWN AND THE COLUMN KEYPAD HAD BEEN DAMAGED. A CONCRETE ROOT CAUSE WAS NOT IDENTIFIED. HOWEVER, BASED ON THE FEEDBACK THE DAMAGED REMOTE CONTROL MOST LIKELY HAS CAUSED THE EVENT. THE DEVICE INVOLVED IN THE EVENT PASSED IT¿S INTENDED LIFETIME OF TEN YEARS. REPLACED THE REMOTE CONTROL AND THE DEVICE WAS WORKING AS EXPECTED. BASED ON THIS, NO FURTHER ACTION IS REQUIRED.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION FOR THE ROOT CAUSE IS CURRENTLY ONGOING. FURTHER INFORMATION WILL BE PROVIDED IN A FINAL REPORT.

    Description of Event or Problem · 0

    CUSTOMER REPORTED THAT OCCASIONALLY THE REMOTE DOES NOT FUNCTION AND ONE DIRECTION OF THE TABLE MOVES UNINTENDED. NO HARM OR IMPACT TO THE SURGICAL PROCEDURE WAS REPORTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT #(B)(4).

    Description of Event or Problem · 0

    CUSTOMER REPORTED THAT OCCASIONALLY THE REMOTE DOES NOT FUNCTION AND ONE DIRECTION OF THE TABLE MOVES UNINTENDED. NO HARM OR IMPACT TO THE SURGICAL PROCEDURE WAS REPORTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    449777 OP-TISCH MARS SELECT DS UNIVERSAL OPERATING TABLE, ELECTROMECHANICAL GDC BAXTER MEDICAL SYSTEMS GMBH + CO. KG 4544310

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown