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

Model Number	INGENIA ELITION S
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	09/16/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Philips received a report of a fire in the ups that is located in the technical room of the mr system.
Additional Manufacturer Narrative
Philips has started an investigation, a follow up will be send when available.
Additional Manufacturer Narrative
The complaint was escalated for technical complaint investigation and the results indicate that there was a failure of a capacitor inside a riello ups delivered by the third party.The capacitors got leaky and led to the generation of smoke (which led to the visible blackened parts) which emitted a burning smell and was sensed by the customer.The ups is an electronic power product, the common failure mode of power electronics often resulting in a burning smell, smoke and blackened components.Note that large electrolytic capacitors as used in this ups are designed to withstand the failure mode "overheating" should that occur and are therefore equipped with a pressure relief valve.This eliminates the possibility for these kinds of capacitors to e.G.Explode.As an immediate containment the 3rd party ups was disconnected and bypassed, so the mains power supply could remain connected to the mri system, and the mri system was then fully functional again.In terms of corrections, the 3rd party ups supplier riello went on site and repaired the impacted ups damaged parts, made the ups functional again and handed it back over to the customer with a sufficient performance analysis.The supplier riello will take corrective actions to resolve the issue with a firmware update in the riello mst 125 ups, and all upss of the same type.

• Brand Name: INGENIA
• 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: 17893238
• Report Number: 3003768277-2023-05179
• Device Sequence Number: 2531869
• Product Code: LNH
• UDI-Device Identifier: 00884838098329
• UDI-Public: 00884838098329
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K173356
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

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: INGENIA ELITION S
• Device Catalogue Number: 782106
• 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: 09/16/2023
• Supplement Date Received by Manufacturer: 09/16/2023
• Initial Report FDA Received Date: 10/09/2023
• Supplement Report FDA Received Date: 02/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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