MAUDE Adverse Event Report: IMRIS-DEERFIELD IMAGING, INC. IMRIS HFD100 SKULL CLAMP ASSEMBLY

Model Number	HFD100 - ORT100/200/300
Medical Device Problem Code	Decrease in Pressure (1490)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The potential slippage in the hfd was traced to the torque screw (pn 111236-600; sn (b)(4)) by the customer service engineer.He observed that, after compression, the torque screw would not return to its fully uncompressed state on its own.The torque screw was returned to the manufacturer for further evaluation and inspection.Manufacturing engineering confirmed that the screw was showing the symptoms that the cs engineer described.Although the internal mechanism was slightly bound up, when the torque screw was tested at 20-40-60-80 lbf.Of torque, it passed testing.Based on the symptoms shown, it appears that the user did not completely clean the device and bio-contamination seeped into the internal mechanism of the screw and prevented the torque screw from functioning properly.
Event or Problem Description
The customer stated that during daily prep, the head fixation device was slipping.There was no patient involved.

• Brand Name: IMRIS HFD100 SKULL CLAMP ASSEMBLY
• Common Device Name: SKULL CLAMP
• Manufacturer (Section D): IMRIS-DEERFIELD IMAGING, INC.; 5101 shady oak road; minnetonka MN 55343 4100
• MDR Report Key: 10605961
• Report Number: 3010326005-2020-00018
• Device Sequence Number: 17098648
• Product Code: HBL
• UDI-Device Identifier: 00857534006011
• UDI-Public: 00857534006011
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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 faci
• Initial Reporter Occupation: Nurse
• Remedial Action: Replace,Inspection
• Type of Report: Initial
• Report Date (Section B): 09/30/2020

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 - ORT100/200/300
• Device Catalogue Number: 113803-000
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2020
• Initial Report FDA Received Date: 09/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1