MAUDE Adverse Event Report: IMRIS - DEERFIELD IMAGING, INC. IMRIS IMRI 3T V; MAGNETIC RESONANCE DIAGNOSTIC DEVICE

Model Number	120823-000
Medical Device Problem Codes	Circuit Failure (1089); Connection Problem (2900); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An imris service engineer went on-site to assess the event and found that user facility personnel had recently performed work that required disconnecting the emergency door release button on an or entry door and reconnecting it after the work was completed.During re-wiring, the circuit was not reconnected properly and the system interlocks read the or entry door as constantly open.The intraoperative sliding doors would not open due to the or entry door open signal and system interlocks functioned as intended to prevent intraoperative sliding doors from opening.The root cause relates to inadvertent user error.If further reportable information is received a supplemental report will be submitted.
Event or Problem Description
The customer reported that the intraoperative sliding doors (rf shielding doors) would not open during a craniotomy for brain tumor removal.An intraoperative mri scan was ordered to determine extent of debulking and whether residual tumor remained.The open-door button was not enabled to allow user to open the intraoperative doors and advance the mri magnet as the status on the control panel was still sensing an open or entry door.The emergency override button was pressed and did not resolve the issue to allow other doors to open.Intraoperative images were not obtained and surgery resumed to close the skull.The patient had postoperative imaging in the diagnostic room which revealed residual tumor.It was reported the care of the patient (meds, monitoring) was not impacted other than the delay of 30 minutes which did not cause harm to the patient.It was also reported further resection was not required.

• Brand Name: IMRIS IMRI 3T V
• Common Device Name: MAGNETIC RESONANCE DIAGNOSTIC 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: 20163871
• Report Number: 3010326005-2024-00009
• Device Sequence Number: 7363002
• Product Code: LNH
• UDI-Device Identifier: 00857534006745
• UDI-Public: (01)00857534006745
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K212367
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• 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): 09/06/2024

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: 120823-000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2024
• Initial Report FDA Received Date: 09/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/15/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 38 YR
• Patient Sex: Male
• Patient Weight: 96 KG