MAUDE Adverse Event Report: BAXTER MEDICAL SYSTEMS GMBH + CO. KG KOPFPLATTE DOPPELGELENK H V; TABLE, OPERATING-ROOM, ELECTRICAL

Model Number	1850955
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is ongoing.All additional and relevant information that is identified following completion of the investigation will be submitted in a final report.
Event or Problem Description
The customer reported that the articulated head section of the operating table broke, causing the patient to fall during a procedure.No injury was reported in relation to this event.This report was filed in our complaint handling system as complaint (b)(4).
Event or Problem Description
The customer reported that the articulated head section of the operating table broke, causing the patient to fall during a procedure.No injury was reported in relation to this event.This report was filed in our complaint handling system as complaint #(b)(4).
Additional Manufacturer Narrative
The field service of baxter performed an onsite investigation at the hospital.The failure " headboard of the pst 300 surgical table broke " could be confirmed.The patient was positioned with the table inverted, without the appropriate replacement of the components, with the hip positioned on top of the headboard.The hip of a heavy patient was positioned on the head section.The head section was used incorrectly and subjected to a heavy load.The head section is designed to support and position the patient¿s head.Based on a massive overload of the head section and the use contrary to the instructions for use, the root cause of the event was traced to a use error.Based on this, no further actions are necessary.

• Brand Name: KOPFPLATTE DOPPELGELENK H V
• Common Device Name: TABLE, OPERATING-ROOM, ELECTRICAL
• Manufacturer (Section D): BAXTER MEDICAL SYSTEMS GMBH + CO. KG; carl-zeiss-strasse 7-9; saalfeld thuringen 07318 ; GM 07318
• Manufacturer Contact: frances coote ; carl-zeiss-strasse 7-9; saalfeld thuringen 07318 ; GM 07318
• MDR Report Key: 21091075
• Report Number: 3007143268-2025-00002
• Device Sequence Number: 21108570
• Product Code: GDC
• UDI-Device Identifier: 00887761970380
• UDI-Public: 00887761970380
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 1850955
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2024
• Supplement Date Received by Manufacturer: 12/11/2024
• Initial Report FDA Received Date: 01/07/2025
• Supplement Report FDA Received Date: 02/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown