MAUDE Adverse Event Report: MAQUET GMBH CF BACK PLATE; TABLE AND ATTACHMENTS, OPERATING-ROOM

Model Number	143334AC
Medical Device Problem Codes	Break (1069); Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information will be provided following the conclusion of the investigation.
Event or Problem Description
Getinge became aware of an issue involving one of our accessories ¿ 143334ac - carbon- fibre back plate for shoulder.According to the report, the accessory broke at the end of the surgery and fell to the floor.The incident occurred while the patient was still sedated on the operating table.The fall caused extubation, as the tube holder was attached to the accessory.The patient was assessed by both the surgeon and the anesthesiologist, with no injuries reported.However, we decided to report this issue due to the potential risk of serious injury if a similar incident, namely accessory breakage leading to the patient's extubation, was to reoccur.

• Brand Name: CF BACK PLATE
• Common Device Name: TABLE AND ATTACHMENTS, OPERATING-ROOM
• Manufacturer (Section D): MAQUET GMBH; kehler strasse 31; rastatt ; GM
• Manufacturer (Section G): MAQUET GMBH; kehler strasse 31; rastatt ; GM
• Manufacturer Contact: diana gutekunst ; kehler strasse 31; rastatt ; GM
• MDR Report Key: 22684775
• Report Number: 8010652-2025-0000030
• Device Sequence Number: 8936872
• Product Code: BWN
• UDI-Device Identifier: 04046768072756
• UDI-Public: (01)04046768072756(11)221012
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/01/2025

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: 143334AC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2025
• Supplement Date Received by Manufacturer: 06/01/2026
• Initial Report FDA Received Date: 08/01/2025
• Supplement Report FDA Received Date: 06/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/12/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Age: 32 YR
• Patient Sex: Male
• Patient Weight: 77 KG