MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION SHOULDER SUSPENSION TOWER; PROTECTOR, SKIN PRESSURE

Model Number	AR-1650-01
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Baxter received a report stating that during a shoulder procedure, a shoulder suspension tower had its blue cord tied to the unit and snapped off during the surgery.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 investigation is ongoing.All additional and relevant information that is identified following completion of the investigation will be submitted in a final report.
Additional Manufacturer Narrative
The shoulder suspension tower is designed to position, support and/or distract the patient¿s shoulder in a variety of surgical procedures including, but not limited to lateral arthroscopic and mini-open shoulder surgery.These devices are intended to be used by healthcare professionals within the operating room setting.The customer alleged that the should suspension tower had its blue cord tied to the unit and snapped off during the surgery and the doctor manually supported the patient's arm.Baxter has contacted the account three times requesting the device to be returned for inspection.The account was unresponsive to the attempts and the device did not return to manufacture.Therefore, baxter is completing this complaint due to the amount of time.Based on this information, no further action is required.Although there was no reported injury with this event, if the report of a blue cord snapping off were to recur, it could potentially cause serious injury or death.Therefore baxter is reporting this event.

• Brand Name: SHOULDER SUSPENSION TOWER
• Common Device Name: PROTECTOR, SKIN PRESSURE
• 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: 23823818
• Report Number: 3010216206-2025-00034
• Device Sequence Number: 9386952
• Product Code: FMP
• UDI-Device Identifier: 00615521004521
• UDI-Public: (01)00615521004521
• 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): 02/16/2026

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-1650-01
• Device Catalogue Number: AR-1650-01
• 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: 11/21/2025
• Supplement Date Received by Manufacturer: 02/11/2026
• Initial Report FDA Received Date: 12/16/2025
• Supplement Report FDA Received Date: 02/16/2026
• 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