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

Model Number	HFD100
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported the head holder for operations assembly is too loose, and that during set up of the equipment for the hfd100 head fixation device, the linkage was loose/wobbly and was replaced prior to a litt procedure.The customer reported the patient did not sustain injury due to the equipment issue, and the procedure was delayed for approximately 5-10 minutes while the linkage components of the subject hfd100 were swapped out for linkage components from an alternate hfd100 at the customer site.The customer reported there was no significant delay or impact on the procedure and the patient tolerated the procedure well.
Additional Manufacturer Narrative
The subject device has returned to the manufacturer and evaluation is in process.A follow up report will be submitted once investigation is complete.

• Brand Name: IMRIS HFD100 - ORT400 IMPERIAL
• Common Device Name: HEAD FIXATION DEVICE
• Manufacturer (Section D): IMRIS - DEERFIELD IMAGING, INC.; 1230 chaska creek way; suite 100; chaska MN 55318
• Manufacturer Contact: paul campbell ; 1320 chaska creek way; suite 100; chaska, MN 55318 ; 7632036344
• MDR Report Key: 16686624
• Report Number: 3010326005-2023-00003
• Device Sequence Number: 12290019
• Product Code: HBL
• UDI-Device Identifier: 00857534006592
• UDI-Public: (01)00857534006592
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K103493
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 04/05/2023

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: HFD100
• Device Catalogue Number: 119629-000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2023
• Initial Report FDA Received Date: 04/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 57 YR
• Patient Sex: Female
• Patient Weight: 77 KG