MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION ALLEN LIFT ASSIST BEACH CHAIR; SUPPORT, PATIENT POSITION

Model Number	A-91501
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2025
Type of Reportable Event	Malfunction
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.The beach chair was received by baxter.Upon inspection, it was determined that the gas shock failed and the back board was broke.Baxter technician replaced the shock and back board.Beach chair now functions as it should.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 beach chair backboard being cracked were to recur, it could potentially cause serious injury or death.Therefore baxter is reporting this event.
Event or Problem Description
Baxter received a report stating that allen lift assist beach chair backboard were cracked and was reclining slightly.The bed was located at the account and occurred during patient use.There was no patient/user injury, no harm or significant impact to the surgical procedure reported.

• Brand Name: ALLEN LIFT ASSIST BEACH CHAIR
• 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: 21577125
• Report Number: 3010216206-2025-00002
• Device Sequence Number: 8751577
• Product Code: CCX
• UDI-Device Identifier: 00615521004125
• UDI-Public: (01)00615521004125
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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
• Report Date (Section B): 03/11/2025

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: Other
• Device Model Number: A-91501
• Device Catalogue Number: A-91501
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2025
• Initial Report FDA Received Date: 03/11/2025
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown