MAUDE Adverse Event Report: BAXTER MEDICAL SYSTEMS GMBH + CO. KG OPERATING TABLE COLUMN TS7500 MOBIUS; TABLE, OPERATING-ROOM, ELECTRICAL

Model Number	1704695
Medical Device Problem Codes	Appropriate Device Problem Term/Code Not Available (3191); Device Fell (4014)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/23/2023
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 during the use of the trusystem 7500 surgical table, as a caregiver was lowering the table, a loud bang was heard, and the table "seemed to drop." the customer confirmed that no injury occurred with this event, no further attempts were made to reposition the bed, and the patient was removed.This report was filed in our complaint handling system as complaint #: (b)(4).
Event or Problem Description
The customer alleged that during the use of the trusystem 7500 surgical table, as a caregiver was lowering the table, a loud bang was heard, and the table "seemed to drop." the customer confirmed that no injury occurred with this event, no further attempts were made to reposition the bed, and the patient was removed.This report was filed in our complaint handling system as complaint (b)(4).
Additional Manufacturer Narrative
During device inspection a broken spindle for the main lift was identified which caused the initial allegation.The spindle was replaced and the device is working as intended.The defect spindle was investigated further by the legal manufacturer and the supplier.A concrete root cause for the defect could not be determined.Based on this, no further action is required.

• Brand Name: OPERATING TABLE COLUMN TS7500 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: daniela avila ; carl-zeiss-strasse 7-9; carl-zeiss-strasse 7-9 07318 ; GM 07318
• MDR Report Key: 17162890
• Report Number: 3007143268-2023-00023
• Device Sequence Number: 14896034
• Product Code: GDC
• UDI-Device Identifier: 00887761976603
• UDI-Public: 887761976603
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/16/2023

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: 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: 05/23/2023
• Supplement Date Received by Manufacturer: 05/23/2023
• Initial Report FDA Received Date: 06/20/2023
• Supplement Report FDA Received Date: 11/16/2023
• 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