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

Model Number HFD100

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/15/2021

Event Type  malfunction  

Manufacturer Narrative

Imris engineer was on-site at the facility to assess the head fixation device and linkages, with no performance or mechanical issues noted.The removable torque screw component involved in the event was removed from the skull clamp and returned to the manufacturing site for evaluation.A follow-up report will be submitted once the investigation into this event is complete.

Event Description

It was reported the frame of the hfd100 slipped while a patient's head was pinned.The patient was in the prone position with 60 lbs of pressure exerted by the torque screw, and all joints were reported to have been checked by two people during pinning and confirmed to be tight.The slippage occurred prior to entering sterile field; there was no negative impact or consequence to the patient or procedure reported.

Manufacturer Narrative

No performance or mechanical issues in the device were found during on-site investigation by an imris engineer at the facility.No discrepancies or anomalies were observed in the returned torque screw component.Preventive maintenance records for the site were reviewed and no discrepancies with respect to the head fixation device or associated linkages were identified.There is a possibility unintended user error related to pinning technique caused or contributed to the event, however this cannot be conclusively determined.

• Brand Name: IMRIS HFD100 HEAD FIXATION DEVICE
• Type of Device: SKULL CLAMP
• 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: 12644511
• MDR Text Key: 281096298
• Report Number: 3010326005-2021-00013
• Device Sequence Number: 1
• Product Code: HBL
• UDI-Device Identifier: 00857534006011
• UDI-Public: (01)00857534006011
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103493
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 10/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HFD100
• Device Catalogue Number: 113803-000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/17/2021
• 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
• Patient Age: 49 YR
• Patient Sex: Male
• Patient Weight: 93 KG