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

Model Number	Head Support
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Pain (1994)
Date of Event	10/10/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A steris surgical service representative inspected the dual articulating headrest assembly and confirmed it to be operating properly.No issues were noted with the function or operation.The user facility requested a non-articulating headrest assembly replacement product.During the time of the reported event, the dual articulating headrest assembly was being utilized with a steris 5095 surgical table.The operator manual for the 5095 surgical table states, "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.Warning - pinching and tipping hazard: patient injury may result if the operator of this table is not completely familiar with the controls for tabletop articulation and table operation." steris performed in-service training on the proper use and operation of the 5095 surgical table and the dual articulating headrest assembly.No additional issues have been reported.
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 the top tilt function was activated.The employee's fingers were released, and the employee was sent to urgent care.

• Brand Name: DUAL ARTICULATING HEADREST ASSEMBLY
• 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 ; 4403927453
• MDR Report Key: 15726693
• Report Number: 1043572-2022-00075
• Device Sequence Number: 2872871
• Product Code: HBM
• UDI-Device Identifier: 00724995195885
• UDI-Public: 00724995195885
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/03/2022

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: Head Support
• Device Catalogue Number: BF753
• 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: 10/10/2022
• Initial Report FDA Received Date: 11/04/2022
• 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