MAUDE Adverse Event Report: BAXTER MEDICAL SYSTEMS GMBH + CO. KG OPERATING TABLE TRUSYSTEM 7000 U (DV); TABLE, OPERATING-ROOM, ELECTRICAL

Model Number	1723633
Medical Device Problem Code	Fire (1245)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	04/10/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Photographs of the device taken by the baxter service technician show the battery burned and caused a fire inside the table housing with smoke development.Further investigation identified the battery was incorrectly installed a couple of days before the event occurred.Following this a collision was possible between the battery and a movable part of the operating table.This collision caused a short circuit inside the battery and a thermal destruction of the battery.The service manual of the operating table indicates clearly the correct installation procedure and to pay attention for the correct installation of the battery.
Event or Problem Description
The customer reported the trusystem 7000 operating table caught on fire leading to smoke in the operating room (or) while a patient was on the table.In this event, a scrub tech reported difficulty breathing at the time of the event and required medical intervention (use of inhalers) to preclude permanent impairment of body function or permanent damage to body structure.The event was temporarily life threatening to the patient and caregivers exposed to the fire and smoke (potentially oxygen rich environment and/or flammable gases present), and therefore, will be considered a serious injury.This report was filed in our complaint handling system as complaint #(b)(4).

• Brand Name: OPERATING TABLE TRUSYSTEM 7000 U (DV)
• 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: 16885412
• Report Number: 3007143268-2023-00012
• Device Sequence Number: 6173786
• Product Code: GDC
• UDI-Device Identifier: 00887761967519
• UDI-Public: 887761967519
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• 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
• Report Date (Section B): 05/08/2023

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: 1723633
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2023
• Initial Report FDA Received Date: 05/08/2023
• 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