MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION BEACH CHAIR POSITIONER; SUPPORT, PATIENT POSITION

Model Number	AR-1627
Medical Device Problem Code	Device Tipped Over (2589)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The 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
Baxter received a report stating that during a total shoulder procedure, a beach chair positioner hydraulic cylinder broke, and the patient immediately reclined and fell flat.The patient was uninjured, and the procedure was finished without incident.No harm or significant impact to the surgical procedure was reported.
Additional Manufacturer Narrative
The beach chair shoulder positioner is designed to position and support the patient¿s head and torso in a variety of surgical procedures including, but not limited to orthopedic surgeries like, rotator cuff, total shoulder, reverse total shoulder, slap repair and other shoulder surgery.These devices are intended to be used by healthcare professionals within the operating room setting.Customer refused to return the associated device and therefore no root cause was able to be determined.Based on this information, no further actions are required at this time.Although there was no reported injury with this event, if the report of a hydraulic cylinder breakage were to recur, it could potentially cause serious injury or death.Therefore baxter is reporting this event.

• Brand Name: BEACH CHAIR POSITIONER
• Common Device Name: SUPPORT, PATIENT POSITION
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): ALLEN MEDICAL SYSTEMS, INC.; 100 discovery way; acton MA 01720
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 23652618
• Report Number: 3010216206-2025-00028
• Device Sequence Number: 4823529
• Product Code: CCX
• UDI-Device Identifier: 00888867020214
• UDI-Public: (01)00888867020214
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/30/2025

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
• Operator of Device: Health Professional
• Device Model Number: AR-1627
• Device Catalogue Number: AR-1627-16
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/05/2025
• Supplement Date Received by Manufacturer: 12/26/2025
• Initial Report FDA Received Date: 11/25/2025
• Supplement Report FDA Received Date: 12/30/2025
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown