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

Model Number	HFD100
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/21/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The hfd100 skull clamp has not yet been returned for evaluation.We anticipate that it will be returned and analyzed.A final report shall be submitted to fda at that time.
Event or Problem Description
During a surgical procedure on (b)(6) 2017, slippage in the extension joints/ linkage of the hfd100 skull clamp assembly occurred.This caused the breathing circuit to become detached.The surgical team readjusted the breathing circuit under the drapes.The incident was considered mainly an inconvenience, the procedure continued after the incident.There were no injuries to the patient.

• Brand Name: HFD100 HEAD FIXATION DEVICE
• Common Device Name: SKULL CLAMP ASSEMBLY
• Manufacturer (Section D): IMRIS - DEERFIELD IMAGING, INC.; 5101 shady oak road; minnetonka MN 55343 4100
• MDR Report Key: 6796769
• Report Number: 3010326005-2017-00007
• Device Sequence Number: 1157260
• Product Code: HBL
• UDI-Device Identifier: 00857534006011
• UDI-Public: 00857534006011
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K103493
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 08/16/2017

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: Nurse
• Device Model Number: HFD100
• Device Catalogue Number: 113803-000
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/21/2017
• Initial Report FDA Received Date: 08/16/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 14 YR
• Patient Weight: 70