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

Model Number	Head Support
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	06/02/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that an employee was repositioning their 4095 surgical table prior to a procedure when their fingers became caught between the end rail and the headboard on the dual articulating headrest assembly resulting in an injury (cut).The employee's fingers were released; it is unknown if medical treatment was sought or administered.
Additional Manufacturer Narrative
A steris service technician arrived onsite to inspect the table and headrest.The technician found that the headrest had been damaged by user facility personnel when releasing the employee's fingers.The user facility will be provided a replacement unit.A steris account manager performed in-service training with user facility personnel on june 29, 2023 on the proper use and operation of the 4095 surgical table, including the headrest.

• 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
• MDR Report Key: 17238050
• Report Number: 1043572-2023-00121
• Device Sequence Number: 20643228
• Product Code: HBM
• UDI-Device Identifier: 00724995195885
• UDI-Public: 00724995195885
• Combination Product (Y/N): N
• Initial Reporter State: DC
• 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): 06/30/2023

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: 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: 06/02/2023
• Initial Report FDA Received Date: 06/30/2023
• 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