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

Model Number	1854087
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	08/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Baxter is in the process of inspecting the tru system 7500 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
The customer reported that table was not having any functionality, and after turning the column off twice and doing one reset still no functionality was obtained.There was no patient/user injury reported.This report was filed in our complaint handling system as complaint # (b)(6).
Event or Problem Description
The customer reported that table was not having any functionality, and after turning the column off twice and doing one reset still no functionality was obtained.There was no patient/user injury reported.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 failure could be confirmed during the inspection.Only the functions from the column where available, the tabletop was not functioning.The cause for the loss of the functionality was traced to the wedges which were no longer fully locking the tabletop into place.There were traces of dried fluids on the wedges, which caused the mechanism to get stuck.As a result, the column no longer recognized the tabletop correctly and therefore the tabletop functions were no longer available.To resolve the problem, the technician replaced the wedges of the carbon tabletop.After repair, the device was working as designed.Based on this, no further actions are required.

• Brand Name: TRUSYSTEM 7500 HYBRID PLUS (FC)
• 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: 20190011
• Report Number: 3007143268-2024-00043
• Device Sequence Number: 8250605
• Product Code: GDC
• UDI-Device Identifier: 00887761996045
• UDI-Public: 887761996045
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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): 11/06/2024

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: 1854087
• 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: 08/16/2024
• Supplement Date Received by Manufacturer: 08/16/2024
• Initial Report FDA Received Date: 09/11/2024
• Supplement Report FDA Received Date: 11/06/2024
• 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