MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. INGENIA 1.5T

Model Number	INGENIA 1.5T
Medical Device Problem Codes	Electrical Overstress (2924); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This complaint is currently under investigation.A supplemental report will be submitted when the investigation has been completed.
Event or Problem Description
The customer reported the power cable connection is cracked and melted.The device was in clinical use at the time, the patient was safely removed from the scanner.As a result, a lot of smoke development and an evacuation of the department, the fire department was dispatched to the customer site.Based on the available information, this issue has been determined to be a reportable event.
Additional Manufacturer Narrative
The reported incident was caused by a failure inside the c78x gradient amplifiers on the connection of the filter output board, this is a known failure mode.The design of the output filter assembly was already changed in the past by adding a current connector, thus limiting the load on the connector.This has already led to an improvement of the reliability of this design per year and a decrease in the number of failures(not even necessarily associated with the connectors).It was therefore decided in the past to replace the old version of the output filter assy by the new version only upon failure.The number of replacements do not support a fundamental change of the policy, that is, replace upon failure.However, as a result of this incident, it was decided to add an additional step in the preventive maintenance procedure to check the torque of the connections and to check the color/status of the connection.
Additional Manufacturer Narrative
Correction was made to the conclusion grid.
Additional Manufacturer Narrative
Correction was made to the conclusion grid.On 05-sep-2024 correction was made to the date received by mfg.

• Brand Name: INGENIA 1.5T
• Common Device Name: INGENIA 1.5T
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.; veenpluis 6; best 5684 PC; NL 5684 PC
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.; veenpluis 6; best 5684 PC; NL 5684 PC
• Manufacturer Contact: dusty leppert ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 16543382
• Report Number: 3003768277-2023-01462
• Device Sequence Number: 14954389
• Product Code: LNH
• UDI-Device Identifier: 00884838009820
• UDI-Public: 884838009820
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K110151
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/05/2024

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: INGENIA 1.5T
• Device Catalogue Number: 781396
• 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: 02/28/2023
• Supplement Date Received by Manufacturer: 02/28/2023; 02/28/2023; 02/28/2023
• Initial Report FDA Received Date: 03/15/2023
• Supplement Report FDA Received Date: 02/12/2024; 02/19/2024; 09/05/2024
• 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