MAUDE Adverse Event Report: IMRIS - DEERFIELD IMAGING, INC. IMRIS HFD100 - ORT400 IMPERIAL; HEAD FIXATION DEVICE

Model Number	HFD100
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow-up report will be submitted once the investigation is complete.
Event or Problem Description
It was reported that a head fixation device (hfd) exhibited too much play during set up prior to pinning the patient during a procedure.The neurosurgeon decided not to use the device in the procedure; no impact to the patient or procedure was reported.
Additional Manufacturer Narrative
The device was evaluated in the field by an imris customer serivce engineer.Investigation through internal corrective action identified the root cause of the reported issue is related to the design of the hfd100 table adapter component that connects to the operating room table and the remainder of the head fixation device assembly.Remedial action has been initiated to replace affected table adapter components in the field with a new component design.

• Brand Name: IMRIS HFD100 - ORT400 IMPERIAL
• Common Device Name: HEAD FIXATION DEVICE
• Manufacturer (Section D): IMRIS - DEERFIELD IMAGING, INC.; 5101 shady oak road; minnetonka MN 55343 4100
• Manufacturer (Section G): IMRIS - DEERFIELD IMAGING, INC.; 5101 shady oak road; minnetonka MN 55343 4100
• Manufacturer Contact: paul campbell ; 5101 shady oak road; minnetonka, MN 55343-4100 ; 7632036344
• MDR Report Key: 12725915
• Report Number: 3010326005-2021-00014
• Device Sequence Number: 6628533
• Product Code: HBL
• UDI-Device Identifier: 00857534006592
• UDI-Public: (01)00857534006592(11)201023
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Remedial Action: Replace,Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2021

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: HFD100
• Device Catalogue Number: 119629-000
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2021
• Supplement Date Received by Manufacturer: 10/01/2021
• Initial Report FDA Received Date: 11/01/2021
• Supplement Report FDA Received Date: 03/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/23/2020
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 3010326005-3/1/22-001-R
• Patient Sequence Number: 1
• Patient Sex: Unknown