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

Model Number	4091000
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	12/19/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reported that the table shut down and would not move despite reset and reboot of table.According to the customer they could not move the table with the column keypad.No harm or impact to the surgical procedure was reported.This report was filed in our complaint handling system as complaint (b)(4).
Additional Manufacturer Narrative
Further investigation should confirm the root cause.Investigation results will be provided within a final report if new information will become available.
Event or Problem Description
Customer reported that the table shut down and would not move despite reset and reboot of table.According to the customer they could not move the table with the column keypad.No harm or impact to the surgical procedure was reported.This report was filed in our complaint handling system as complaint # (b)(4).
Additional Manufacturer Narrative
The log files of the device were reviewed and it could be confirmed a loss of function was recorded.According to the customer the tabletop was removed manually from the column after the event and surgical procedure.Following this the device was working as intended.A concrete root cause could not be determined.It is possible that a loss of contact between column and tabletop caused the malfunction.The loss of contact may have occurred by a foreign object between those two parts or a not correct fixed tabletop onto the column.No repair or exchange of a part was necessary.Based on this, no further action is required.

• Brand Name: TRUSYSTEM 7500
• 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: 16033015
• Report Number: 3007143268-2022-00031
• Device Sequence Number: 17940355
• Product Code: GDC
• UDI-Device Identifier: 00887761984455
• UDI-Public: 887761984455
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/16/2023

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: 4091000
• 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: 12/19/2022
• Supplement Date Received by Manufacturer: 12/19/2022
• Initial Report FDA Received Date: 12/22/2022
• Supplement Report FDA Received Date: 03/16/2023
• 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