MAUDE Adverse Event Report: IMRIS - DEERFIELD IMAGING, INC. HC150 FLEXIBLE INTRAOPERATIVE HEAD COIL; COIL, MAGNETIC RESONANCE, SPECIALTY

Model Number	HC150
Medical Device Problem Codes	Break (1069); Intermittent Continuity (1121); Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/20/2022
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2022, it was reported that an imris lower flex coil failed to function when used for intra-operative mr imaging.The neurosurgeon had requested an intra-operative brain scan after tumor removal and a system error message was produced when the lower flex coil was plugged in.The mr magnet was returned to home position, power cycled, and then returned to the operating room; however, this did not resolve the error.The coil was unsuccessfully plugged into a different port as well.The upper flex coil was then moved to the lower position, and a wireless insitu coil was used in the upper position, and imaging was then successfully obtained.The patient was under extended anesthesia for approximately two hours at the surgeon's discretion during troubleshooting before the imaging was produced.The imaging results confirmed there was no remaining tumor to resect, and no patient harm was reported as a result of the delay or extended time under anesthesia.
Additional Manufacturer Narrative
The flex coil was returned for analysis and showed signs of excessive wear.A shock indicator was tripped indicating prior mechanical shock.The connection point of the cable assembly to the coil assembly showed signs of fracture or disengagement as well as attempted user repair with gauze or tape.Based on age, the coil is past its useful service life.Based on communications with the reporter, the coil passed a site quality assurance check two days prior to the case, and it is possible the coil could perform intermittently in its condition.The probable root cause of the reported functional issue is age past service life and condition as a result of handling.

• Brand Name: HC150 FLEXIBLE INTRAOPERATIVE HEAD COIL
• Common Device Name: COIL, MAGNETIC RESONANCE, SPECIALTY
• 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: 14465859
• Report Number: 3010326005-2022-00007
• Device Sequence Number: 4515993
• Product Code: MOS
• UDI-Device Identifier: 00857534006240
• UDI-Public: (01)00857534006240
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K103506
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/20/2022

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: HC150
• Device Catalogue Number: 110821-000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/20/2022
• Initial Report FDA Received Date: 05/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/12/2012
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Age: 6 YR
• Patient Sex: Female
• Patient Weight: 23 KG