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	Key or Button Unresponsive/not Working (4063)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/24/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Baxter is in the process of inspecting the trusystem 7000dv operating table.There was no allegation of patient or caregiver injury or death reported from this alleged incident.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
It was reported that when patient was on the table, the case was delayed because the table would not move.The trusystem 7000dv operating table drive malfunctioned and table was locked but showing unlocked.Additionally, an error code 429 was reported.The table was being used on both battery and ac with no change.The customer reset the table with no change and the table would not lock or unlock with the keypad or remote.No patient injury was reported, and the patient was transferred to a different table.This report was filed in our complaint handling system as complaint (b)(4).
Event or Problem Description
It was reported that when patient was on the table, the case was delayed because the table would not move.The trusystem 7000dv operating table drive malfunctioned and table was locked but showing unlocked.Additionally, an error code 429 was reported.The table was being used on both battery and ac with no change.The customer reset the table with no change and the table would not lock or unlock with the keypad or remote.No patient injury was reported, and the patient was transferred to a different table.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 cause of the failure of the operating table functions was found to be a short circuit on the can distributor board.This was caused by the ingress of fluids.The failure was resolved by exchange of the can distributor ts.Based on this, no further action is required.

• 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: 19962858
• Report Number: 3007143268-2024-00035
• Device Sequence Number: 7037609
• Product Code: GDC
• UDI-Device Identifier: 00887761989719
• UDI-Public: 887761989719
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/18/2024

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
• 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: 07/24/2024
• Supplement Date Received by Manufacturer: 07/24/2024
• Initial Report FDA Received Date: 08/12/2024
• Supplement Report FDA Received Date: 10/18/2024
• 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