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

Model Number INGENIA 1.5T

Device Problems Electrical Overstress (2924); Insufficient Information (3190)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/23/2023

Event Type  malfunction  

Manufacturer Narrative

This complaint is currently under investigation.A supplemental report will be submitted when the investigation has been completed.

Event 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.

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.

Manufacturer Narrative

Correction was made to the conclusion grid.

• Brand Name: INGENIA 1.5T
• Type of Device: 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
• MDR Text Key: 311290220
• Report Number: 3003768277-2023-01462
• Device Sequence Number: 1
• Product Code: LNH
• UDI-Device Identifier: 00884838009820
• UDI-Public: 884838009820
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K110151
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 02/28/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1