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

Model Number	Head Support
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Numbness (2415)
Date of Event	07/12/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A steris account manager was informed of the event that occurred with the dual articulating headrest assembly on (b)(6) 2022.The account manager went to the user facility to perform the in service for the surgical table and headrest on 7/18/2022.The user facility personnel utilized their 4095 surgical table and dual articulating headrest assembly prior to the scheduled in-service training, which is when the event occurred.The employee subject of the reported event attempted to attach the headrest onto their 4095 surgical table.While attempting to attach the headrest the employee squeezed the left lever of the dual articulating headrest assembly resulting in the employee's fingers being pinched in a pinch point of the device.The steris 4095 general surgical table operator manual safety and precautions section 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 tabletop operation." the account manager inspected the headrest and found it to be operating according to specification.The account manager conducted the in-service training on the use and operation of the 4095 surgical table, including use of the dual articulating headrest assembly.No additional issues have been reported.
Event or Problem Description
The user facility reported that an employee obtained an injury to their fingers while adjusting their dual articulating headrest assembly (pinch/numbness).The user facility did not disclose if medical treatment was sought or administered.

• 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 ; 4403927453
• MDR Report Key: 15213824
• Report Number: 1043572-2022-00053
• Device Sequence Number: 5567008
• Product Code: HBM
• UDI-Device Identifier: 00724995195885
• UDI-Public: 00724995195885
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 08/11/2022

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: 07/12/2022
• Initial Report FDA Received Date: 08/11/2022
• 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