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

Model Number HFD100

Device Problem Mechanical Problem (1384)

Patient Problem Laceration(s) (1946)

Event Date 12/13/2023

Event Type  malfunction  

Manufacturer Narrative

Further detailed information has been requested by the manufacturer regarding the procedure, patient demographics and final outcome.Analysis of the skull clamp assembly of the hfd was completed by an imris service engineer at the customer site and found no performance issues.The torque screw utilized in the procedure is being returned for analysis to support the investigation; a followup report will be submitted at the investigation conclusion and with any further reportable information received from the customer.

Event Description

A customer reported that the patient suffered a laceration after use of the imris hfd100 head fixation device.It was reported that 80 pounds of pressure was used to pin the patient's head, and that upon removal of the device at the conclusion of the procedure, the skull clamp appeared quite loose and promptly fell off the patient, which caused the laceration.No further details were reported and the manufacturer has requested further information from the customer site.

• Brand Name: IMRIS HFD100
• Type of Device: HEAD FIXATION DEVICE
• Manufacturer (Section D): IMRIS - DEERFIELD IMAGING, INC.; 1230 chaska creek way; suite 100; chaska MN 55318
• Manufacturer Contact: paul campbell ; 1230 chaska creek way; suite 100; chaska, MN 55318 ; 7632036344
• MDR Report Key: 18531709
• MDR Text Key: 333349205
• Report Number: 3010326005-2024-00001
• Device Sequence Number: 1
• Product Code: HBL
• 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,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 01/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2024
• 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: 111542-000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/18/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/27/2012
• 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 Outcome(s): Other
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Race: White