MAUDE Adverse Event Report: PHILIPS ELECTRONICS NEDERLAND B.V. INGENIA 1.5T; SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING

Model Number	INGENIA 1.5T R5 BASED
Medical Device Problem Codes	Insufficient Device Problem Information (3190); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/08/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Philips has started an investigation.A follow up report will be send when the investigation has been completed.
Event or Problem Description
Philips received a report that thick smoke emanated from the gantry, source unknown.
Additional Manufacturer Narrative
Background: on 08-mar-2023 philips received a complaint from a customer that an event occurred with the philips mri system.The customer indicated that after the patient scanning was done and the staff went home.A few hours later the cleaning crew entered the building around 22:00 and noticed a slight smell of smoke and observed smoke.The cleaning crew called the fire department who showed up onsite and hit both emergency ramp down unit (erdu) buttons before the customer got onsite.No source of heat or fire was found, and no extinguishing fluid was used.No harm was reported.Around 01:00 in the night two philips service engineers arrived.In the examination room, they removed the covers around the magnet and checked all parts.There was no sign of damage inside or outside the mri system components.No deviations were found.The system was powered up and cooling of the magnet was secured.However, days later an uninterruptible power supply (ups) (schneider galaxy vm) failure occurred, there was damage on the printed circuit board assembly (pcba) this was encountered in the ups that is connected to the mr device.The ups is a third party product not owned by philips.Philips is not the manufacturer, nor the design owner of this product.This ups has since been repaired.The ups in question is a schneider galaxy vm 160kva full system ups , serial nr.(b)(6).Conclusion: the event happened in the night at 22:00.The mri system was not in use at the time of the event, it was in standby mode.There were no injuries from the incident.The mr device was not in clinical use at the time.Based on the information provided, it has been confirmed that no death or serious injury occurred as a result of the reported incident.It is concluded that the mentioned smoke can be attributed to the early stages of the failure of the ups.The damage to the ups is not attributed to the mr device.

• Brand Name: INGENIA 1.5T
• Common Device Name: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): PHILIPS ELECTRONICS NEDERLAND B.V.; veenpluis 6; best 5684 PC; NL 5684 PC
• Manufacturer (Section G): PHILIPS ELECTRONICS NEDERLAND B.V.; veenpluis 6; best 5684 PC; NL 5684 PC
• Manufacturer Contact: dusty leppert ; 222 jacobs street; cambridge, MA 02141
• MDR Report Key: 16583210
• Report Number: 3003768277-2023-01801
• Device Sequence Number: 20007206
• Product Code: LNH
• UDI-Device Identifier: 00884838055322
• UDI-Public: 884838055322
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K163116
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2024

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
• Device Model Number: INGENIA 1.5T R5 BASED
• Device Catalogue Number: 781341
• 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: 03/08/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/21/2023
• Supplement Report FDA Received Date: 08/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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