MAUDE Adverse Event Report: BAXTER MEDICAL SYSTEMS GMBH + CO. KG HEAD SECTION DOUBLE JOINT H U V; TABLE, OPERATING-ROOM, ELECTRICAL

Model Number	1853828
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reported the head section of the operating table was floating up.No patient injury was reported.This report was filed in our complaint handling system as complaint # (b)(4).
Additional Manufacturer Narrative
Technician readjusted gas pressure spring.Issue resolved.Investigation into the root cause is pending and results will be provided in a final report.
Event or Problem Description
Customer reported the head section of the operating table was floating up.No patient injury was reported.This report was filed in our complaint handling system as complaint # (b)(4).
Additional Manufacturer Narrative
The device was inspected by a field service technician and the release mechanism of the gas spring was readjusted.A component or manufacturing failure could not be identified.The release mechanism was disadjusted either by external forces or other unknown manipulation.After the correction the device was working as designed.Based on this, no further action is necessary.

• Brand Name: HEAD SECTION DOUBLE JOINT H U V
• 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: 16909897
• Report Number: 3007143268-2023-00014
• Device Sequence Number: 17684785
• Product Code: GDC
• UDI-Device Identifier: 00887761991453
• UDI-Public: 887761991453
• Combination Product (Y/N): N
• 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): 07/17/2023

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: 1853828
• 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: 04/17/2023
• Supplement Date Received by Manufacturer: 04/17/2023
• Initial Report FDA Received Date: 05/11/2023
• Supplement Report FDA Received Date: 07/17/2023
• 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