BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUMPF MEDICAL

    MDR report key: 23872421 · Received December 22, 2025

    Report

    Report Number
    3007143268-2025-00093
    Event Type
    Malfunction
    Date Received
    December 22, 2025
    Date of Event
    November 11, 2025
    Report Date
    January 12, 2026
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    GDC
    UDI-DI
    00887761979390
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS ONGOING. ALL ADDITIONAL AND RELEVANT INFORMATION THAT IS IDENTIFIED FOLLOWING COMPLETION OF THE INVESTIGATION WILL BE SUBMITTED IN A FINAL REPORT.

    Additional Manufacturer Narrative · 0

    THE OPERATING TABLE INVOLVED WAS INSPECTED BY A BAXTER FIELD SERVICE TECHNICIAN. THE ALLEGATION OF HYDRAULIC (FOOT) STAMP WAS DISENGAGING ON ITS OWN COULD BE CONFIRMED. BAXTER EXCHANGED THE OPERATING TABLE AT THE CUSTOMER LOCATION FOR FURTHER INVESTIGATION AT THE MANUFACTURERS PLANT. DURING THIS INVESTIGATION THE CAUSE WAS TRACED TO THE HYDRAULIC UNIT. AFTER THE REPLACEMENT OF THIS PART, THE DEVICE WAS WORKING AS INTENDED. THE ROOT CAUSE OF THE HARDWARE DEFECT WAS NOT IDENTIFIED YET. THE ALLEGED FAILURE MODE WILL BE MONITORED FURTHER VIA POST-MARKET SURVEILLANCE ACTIVITIES AND THE INVESTIGATION FOR THE ROOT CAUSE WILL PROCEED FURTHER.

    Description of Event or Problem · 0

    ON 25-NOV-2025, A OTHER HEALTH CARE PROFESSIONAL CONTACTED TECHNICAL SERVICE TO REPORT THAT PST 500 (PRODUCT CODE 4080100, SERIAL NUMBER (B)(6)), HAD AN ISSUE, THE BRAKES DO NOT EXTEND EVENLY, CAUSING THE OPERATING TABLE TO WOBBLE. ONE BRAKE RELEASES INTRAOPERATIVELY, CAUSING THE OPERATING TABLE TO WOBBLE. THIS OCCURRED DURING PATIENT USE. THERE WAS NO PATIENT INJURY OR DEATH REPORTED WITH THIS EVENT.

    Description of Event or Problem · 0

    ON (B)(6) 2025, A OTHER HEALTH CARE PROFESSIONAL CONTACTED TECHNICAL SERVICE TO REPORT THAT PST 500 (PRODUCT CODE 4080100, SERIAL NUMBER (B)(6), HAD AN ISSUE, THE BRAKES DO NOT EXTEND EVENLY, CAUSING THE OPERATING TABLE TO WOBBLE. ONE BRAKE RELEASES INTRAOPERATIVELY, CAUSING THE OPERATING TABLE TO WOBBLE. THIS OCCURRED DURING PATIENT USE. THERE WAS NO PATIENT INJURY OR DEATH REPORTED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1564085 TRUMPF MEDICAL TABLE, OPERATING-ROOM, ELECTRICAL GDC BAXTER HEALTHCARE CORPORATION 4080100 N/A 00887761979390

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown