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

Model Number Head Support

Device Problem Use of Device Problem (1670)

Patient Problem Pain (1994)

Event Date 10/10/2022

Event Type  malfunction  

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 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
• Type of Device: 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
• MDR Text Key: 304413268
• Report Number: 1043572-2022-00075
• Device Sequence Number: 1
• Product Code: HBM
• UDI-Device Identifier: 00724995195885
• UDI-Public: 00724995195885
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: Head Support
• Device Catalogue Number: BF753
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1