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

Model Number	1704695
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	05/08/2023
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 trusystem 7500 of the mobius airo ct system is not operating anymore.No operation was possible from the remote control and the column keypad.No harm was reported in relation to the allegation.This report was filed in our complaint handling system as complaint #(b)(4).
Additional Manufacturer Narrative
During on-site investigation it was confirmed that only the remote control did not work caused by an empty battery.The remote control was exchanged and the operating table could be adjusted again using this new remote control.In case the remote control will not work the user is able to adjust the table function by the column control unit.It could no be clarified why it was initially alleged that also the column control keypad was not working.During inspection no problem, defect or malfunction was found with it.No impact to a surgical procedure, patient or user was reported.Based on this no further actions are required.
Event or Problem Description
The customer alleged that the operating table trusystem 7500 of the mobius airo ct system is not operating anymore.No operation was possible from the remote control and the column keypad.No harm was reported in relation to the allegation.This report was filed in our complaint handling system as complaint #(b)(4).

• Brand Name: OP-TISCHSÄULE TRUSYSTEM 7500 MOBIUS
• 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: 16992315
• Report Number: 3007143268-2023-00018
• Device Sequence Number: 3491444
• Product Code: GDC
• UDI-Device Identifier: 00887761976603
• UDI-Public: 887761976603
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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): 07/26/2023

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: 1704695
• 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: 05/08/2023
• Supplement Date Received by Manufacturer: 05/08/2023
• Initial Report FDA Received Date: 05/24/2023
• Supplement Report FDA Received Date: 07/26/2023
• 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