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

Model Number HFD100

Device Problems Detachment Of Device Component (1104); Device Slipped (1584)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/21/2017

Event Type  malfunction  

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 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
• Type of Device: SKULL CLAMP ASSEMBLY
• 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: sanjay shah ; 5101 shady oak road; minnetonka, MN 55343-4100 ; 7632036380
• MDR Report Key: 6796769
• MDR Text Key: 83152683
• Report Number: 3010326005-2017-00007
• Device Sequence Number: 1
• Product Code: HBL
• UDI-Device Identifier: 00857534006011
• UDI-Public: 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 faci
• Reporter Occupation: Nurse
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 08/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: HFD100
• Device Catalogue Number: 113803-000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/24/2016
• 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: 14 YR
• Patient Weight: 70