MAUDE Adverse Event Report: STERIS CORPORATION DUAL ARTICULATING HEADREST

Model Number	HEAD SUPPORT
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/13/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A steris service technician arrived onsite to inspect the dual articulating headrest assembly and confirmed the reported issue.The user facility will be provided with a replacement headrest.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 headrest.As a result, there was resistance within the locking mechanism causing it to not properly lock into place.Assembly staff were re-trained on the proper application of the loctite.Additionally, all current inventory was inspected.A 3-year complaint review indicates this to be an isolated event.No additional issues have been reported.
Event or Problem Description
The user facility reported that during a patient procedure, their dual articulating headrest assembly would not lock into position.The procedure was completed successfully with another headrest assembly.No report of injury.
Additional Manufacturer Narrative
The user facility was provided with a replacement head rest.Contrary to the initial mdr, the head rest has not been returned to steris for evaluation.The head rest was removed from service and evaluated by the steris service technician onsite at the user facility.The technician provided pictures of the head rest to steris quality 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 HEADREST
• Common Device Name: HEADREST
• 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: 18094164
• Report Number: 1043572-2023-00159
• Device Sequence Number: 6254363
• Product Code: HBM
• UDI-Device Identifier: 00724995195885
• UDI-Public: (01)00724995195885(11)230926
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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,Followup
• Report Date (Section B): 11/08/2023

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: 10/13/2023
• Supplement Date Received by Manufacturer: 10/13/2023; Not provided
• Initial Report FDA Received Date: 11/08/2023
• Supplement Report FDA Received Date: 11/29/2023; 01/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/26/2023
• 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