MAUDE Adverse Event Report: PHILIPS ELECTRONICS NEDERLAND B.V. MR 7700

Model Number	MR 7700
Medical Device Problem Codes	Insufficient Device Problem Information (3190); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/19/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Philips has started an investigation, a follow up report will be submitted after this investigation.
Event or Problem Description
Philips received a report of a gradient coil failure leading to burning smell and visual damage.
Additional Manufacturer Narrative
The system was suffering from spikes from an unknown origin which caused the interlock safety to activate.It was then decided to replace the gradient coil in light of previous gradient coil issues on other sites it was concluded that the spikes were definitely not originating from the gradient coil, busbars or the gradient cables.It turned out that the gradient coil was replaced by mistake as it was already the new model.A system malfunction in the system as the cause for the spikes was ruled out.Therefore, the spike detection threshold was relaxed on this system to allow the customer to continue scanning without triggering the system interlock for spikes.In the end the source of the spikes were traced back to cabling in the patient support and there were also external influences identified.( room exit light).

• Brand Name: MR 7700
• Common Device Name: MR 7700
• 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: 17621953
• Report Number: 3003768277-2023-04632
• Device Sequence Number: 7545539
• Product Code: LNH
• UDI-Device Identifier: 00884838104112
• UDI-Public: 00884838104112
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• PMA/510(K) Number: K223442
• 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
• Report Date (Section B): 09/04/2024

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: MR 7700
• Device Catalogue Number: 782120
• 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: 07/19/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/25/2023
• Supplement Report FDA Received Date: 09/04/2024
• 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