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

Model Number	Table Pad
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/10/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There was no patient or procedure involvement associated with the reported event.A steris account manager arrived onsite and discussed the reported event with user facility personnel.Through follow up, it was determined that the employee subject of the reported event had her fingers in a pinch point when she was articulating the headrest.No issues were noted with the function or operation of the headrest assembly.User facility personnel utilized the headrest prior to their scheduled in-service training.During the time of the reported event, the dual articulating headrest assembly was being utilized with a steris 4095 surgical table.The operator manual for the 4095 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." while onsite, the steris account manager counseled user facility personnel on the proper use and operation of the dual articulating headrest assembly.No additional issues have been reported.
Event or Problem Description
The user facility reported that an employee's fingers got caught between the end rail and the headboard on their dual articulating headrest assembly when she was raising the head section.The user facility declined to provide information regarding if the employee sought or received medical treatment.

• 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: 15392650
• Report Number: 1043572-2022-00060
• Device Sequence Number: 4905446
• Product Code: HBM
• UDI-Device Identifier: 00724995191139
• UDI-Public: 00724995191139
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Report Date (Section B): 09/09/2022

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: Table Pad
• Device Catalogue Number: BF752
• 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: 08/10/2022
• Initial Report FDA Received Date: 09/09/2022
• 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