MAUDE Adverse Event Report: BAXTER MEDICAL SYSTEMS GMBH + CO. KG OP-TISCHSÄULE TRUSYSTEM 7500 SF; TABLE, OPERATING-ROOM, ELECTRICAL

Model Number	1717020
Medical Device Problem Codes	No Apparent Adverse Event (3189); Key or Button Unresponsive/not Working (4063)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Inspection of the device is pending and results will be provided by a final report.
Event or Problem Description
The customer alleged that the operating table froze while anesthetizing the patient and gives power supply error.No harm or injury to patient or caregiver was reported.This report was filed in our complaint handling system as complaint # (b)(4).
Additional Manufacturer Narrative
During inspection the root cause was traced to the power supply of the operating table.The power supply unit was exchanged by our finish service partner.Further investigation of the power supply and the log files of the device concluded a temporary software failure caused the table to ¿freeze¿.According to the ifu of the device the reset function is described to eliminate temporary failures.This will allow the user to bring back the functionality of the operating table within a short timeframe.Our risk file indicates that there is no death or serious deterioration in the state of health imaginable for this failure mode.Therefore, this complaint is considered not reportable.
Event or Problem Description
The customer alleged that the operating table froze while anesthetizing the patient and gives power supply error.No harm or injury to patient or caregiver was reported.This report was filed in our complaint handling system as complaint # (b)(4).

• Brand Name: OP-TISCHSÄULE TRUSYSTEM 7500 SF
• 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: 16384676
• Report Number: 3007143268-2023-00001
• Device Sequence Number: 5605451
• Product Code: GDC
• UDI-Device Identifier: 00887761985865
• UDI-Public: 887761985865
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• 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): 04/13/2023

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: 1717020
• 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: 02/01/2023
• Supplement Date Received by Manufacturer: 02/01/2023
• Initial Report FDA Received Date: 02/16/2023
• Supplement Report FDA Received Date: 04/13/2023
• 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