MAUDE Adverse Event Report: STERIS CORPORATION - MONTGOMERY SHOULDER CHAIR ASSEMBLY

Model Number	SHOULDER CHAIR
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/06/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Through follow-up with user facility personnel, steris was able to confirm that the patient was positioned on a shoulder chair assembly that was being utilized with a steris 5085 surgical table during the time of the reported event.A steris clinical support representative and a steris procedural sales representative confirmed that no issues were noted with the shoulder chair assembly, or 5085 surgical table following the reported event and found the devices to be operating properly.The steris instructions for use powerlift beach chair for cmax, steris 4085 general, steris 5085 srt, steris 5085 general and steris 5085 harmony surgical tables (rev a) p056404-439 states in patient positioning; warning - personal injury hazard: when positioning the patient on the powerlift beach chair, ensure the patient's head, arms and torso are supported.To ensure patient stability, before articulating surgical table or powerlift beach chair, secure patient in accordance with recommended positioning practices.Prevent possible injury to patient's head and neck.Before securing forehead and chin straps, ensure correct alignment of patient's head and body.Support patient's head whenever adjusting headrest.The steris representatives offered in-service training on the proper use of the shoulder chair that is utilized with steris surgical tables and the user facility accepted.Steris is working with the user facility to schedule a date in march 2023.The shoulder chair assembly and 5085 surgical table were returned to service and no additional issues have been reported.
Event or Problem Description
The user facility reported via medwatch report (b)(4) that during a patient procedure the patient's head slid out of the positioner.The procedure was completed successfully, and no injuries were reported.
Additional Manufacturer Narrative
Steris offered in-service training on the proper use of the shoulder chair that is utilized with steris surgical tables however, the user facility declined.No additional issues have been reported.

• Brand Name: SHOULDER CHAIR ASSEMBLY
• Common Device Name: SHOULDER CHAIR
• Manufacturer (Section D): STERIS CORPORATION - MONTGOMERY; 2720 gunter park drive east; montgomery AL 36109
• Manufacturer (Section G): STERIS CORPORATION - MONTGOMERY; 2720 gunter park drive east; montgomery AL 36109
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060 ; 4403927453
• MDR Report Key: 16514295
• Report Number: 1043572-2023-00061
• Device Sequence Number: 6296882
• Product Code: GBB
• UDI-Device Identifier: 00724995179786
• UDI-Public: 00724995179786
• Combination Product (Y/N): N
• Initial Reporter State: RI
• 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: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: SHOULDER CHAIR
• Device Catalogue Number: BF594
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2023
• Supplement Date Received by Manufacturer: 02/07/2023
• Initial Report FDA Received Date: 03/09/2023
• Supplement Report FDA Received Date: 03/31/2023
• 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