MAUDE Adverse Event Report: IMRIS - DEERFIELD IMAGING, INC IMRIS HC300 IOHV2 HEAD FLEX COIL; MAGNETIC RESONANCE IMAGING COIL

Model Number	HC300
Medical Device Problem Code	Temperature Problem (3022)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/05/2019
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2019, a healthy volunteer underwent scanning and experienced heat from the flex coil.There was no harm or user injury reported due to the event.
Additional Manufacturer Narrative
The volunteer was prone in a modified superman position.The imris flex coils were used and positioned on the volunteer's sides; one on the left with the coil cable going up and then down toward the feet.The other flex coil was on the right side of the volunteer in the same position.The flex coils were padded between the volunteer with a towel and wrapped with a flex wrap around the bed, body, and coils to hold them secured.Scanning was approximately forty-five minutes and round the forty-minute mark, the volunteer felt the left side coil become warmer.At the start of the next scan, the feeling became intense with heat and unbearable.The volunteer informed the staff of the discomfort and the scan was stopped.The mri and unrolled tape was removed and there were no red marks of heat or burn visible on the volunteer's skin.The customer did not return the coil(s) in question and continued to use them.The coils were tested previously by the manufacturer during preventive maintenance and were found to be performing within specification.In addition, the coils undergo daily qa testing by an or staff prior to any patient procedure.The particular serial numbers of the coils involved were not identified by the customer.This mdr is being submitted outside of the required timeframe as part of remedial action initiated by the manufacturer, in response to internally identified issues regarding failed electronic submissions through webtrader.

• Brand Name: IMRIS HC300 IOHV2 HEAD FLEX COIL
• Common Device Name: MAGNETIC RESONANCE IMAGING COIL
• 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: kwaku amoah ; 5101 shady oak road; minnetonka, MN 55343-4100 ; 7632036344
• MDR Report Key: 13441387
• Report Number: 3010326005-2019-00029
• Device Sequence Number: 11842628
• Product Code: MOS
• UDI-Device Identifier: 00857534006233
• UDI-Public: 00857534006233
• Combination Product (Y/N): N
• Initial Reporter State: NH
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 09/05/2019

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: HC300
• Device Catalogue Number: 110833-000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2019
• Initial Report FDA Received Date: 02/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Sex: Unknown