MAUDE Adverse Event Report: STERIS CORPORATION DUAL ARTICULATING HEAD REST

Model Number	HEAD SUPPORT
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that during a patient procedure, their dual-articulating head rest lowered from its locked position.The head rest was repositioned and the procedure was completed without further issue.The patient was taken for x-rays post-procedure as a precaution.
Additional Manufacturer Narrative
A steris service technician arrived onsite to inspect the dual articulating head rest and confirmed the reported issue.The user facility will be provided with a replacement head rest.The headrest subject of the reported event was returned to steris for evaluation.The evaluation concluded that an excessive amount of loctite was applied during the assembly process of the head rest.This can cause loctite to be present in the gear grooves, not allowing the locking mechanism (pawl) to be fully seated within the gear.In some cases, partial seating could occur; additional/incidental movement of the patient's head or by contact of the head rest from user facility personnel could cause the pawl to come out of the gear.Assembly staff were re-trained on the proper application of the loctite.Additionally, all current on-hand inventory was inspected.Steris has confirmed the reported issue.Steris initiated a recall of affected head rests on 11/28/2023.
Additional Manufacturer Narrative
Udi related data quality updates only - alignment with gudid.

• Brand Name: DUAL ARTICULATING HEAD REST
• Common Device Name: HEAD REST
• Manufacturer (Section D): STERIS CORPORATION; 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: 18234369
• Report Number: 1043572-2023-00164
• Device Sequence Number: 11569455
• Product Code: HBM
• UDI-Device Identifier: 00724995195885
• UDI-Public: (01)00724995195885(11)231024
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/29/2023

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: 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: 11/01/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/29/2023
• Supplement Report FDA Received Date: 01/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/24/2023
• 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