MAUDE Adverse Event Report: STERIS CORPORATION - MONTGOMERY DUAL ARTICULATING HEADREST

Model Number	BF754
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Pain (1994)
Date of Event	08/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that an employee inadvertently pinched their fingers between the headboard and end rail on their dual articulating headrest assembly when attempting to remove the headrest from the table.The employee's fingers were released, and the employee was sent to the emergency department.The user facility did not disclose if medical treatment was administered.Report of procedure delay.
Additional Manufacturer Narrative
Steris has requested the dual articulating headrest assembly be returned for evaluation.At the time of the reported event, the dual articulating headrest assembly was being utilized with a steris 5095 surgical table.The 5095 surgical table operator manual states, (1) "warning-pinching hazard: pinch points are created during tabletop articulation.Become familiar with all pinch points prior to operating the table.To avoid serious injury, keep limbs, fingers and other body areas clear of all pinch points when positioning the table.When manually positioning table sections, stay clear of potential pinching hazards." steris has offered in-service training on the proper use and operation of the 5095 surgical table and dual articulating headrest assembly; however, we are awaiting a response.A follow-up report will be submitted when additional information becomes available.
Additional Manufacturer Narrative
Steris has made multiple attempts to facilitate the return of the dual articulating headrest assembly subject of the reported event however, the user facility has not responded.Steris performed in-service training with user facility personnel on the proper use and operation of the 5095 surgical table and dual articulating headrest assembly.No additional issues have been reported.

• Brand Name: DUAL ARTICULATING HEADREST
• Common Device Name: HEADREST
• 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
• MDR Report Key: 17826575
• Report Number: 1043572-2023-00142
• Device Sequence Number: 14038996
• Product Code: HBM
• UDI-Device Identifier: 00724995197643
• UDI-Public: 00724995197643
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/27/2023

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: BF754
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2023
• Supplement Date Received by Manufacturer: 08/31/2023
• Initial Report FDA Received Date: 09/27/2023
• Supplement Report FDA Received Date: 03/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/09/2022
• 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