MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. SMARTPATH TO DSTREAM FOR 1.5T; FULL-BODY MRI SYSTEM, SUPERCONDUCTING MAGNET

Model Number	SMARTPATH TO DSTREAM FOR 1.5T
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Philips received a report that the quadrature body coil (qbc) seal was peeled off a tape from inside the magnet.This seal is used for protection, to avoid the patient from potentially contacting the sharp edges of the magnet covers.If this seal is peeled off a tape from inside the magnet it is likely that this could lead to serious injury.
Additional Manufacturer Narrative
The qbc seal that was peeled off a tape from inside the magnet was replaced and the system was handed back to the customer for use.The failure of the qbc seal to remain in place is considered a malfunction.Remedial action: a field action was initiated under 2023-pd-mr-013.A field safety notification was sent to the customers informing them about this potential issue.The field correction has since been made available to the field in dec 2024.

• Brand Name: SMARTPATH TO DSTREAM FOR 1.5T
• Common Device Name: FULL-BODY MRI SYSTEM, SUPERCONDUCTING MAGNET
• 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 ; 222 jacobs street; cambridge, MA 02141
• MDR Report Key: 23539570
• Report Number: 3003768277-2025-014478
• Device Sequence Number: 18473392
• Product Code: LNH
• UDI-Device Identifier: 00884838108691
• UDI-Public: (01)00884838108691
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K063559
• 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
• Remedial Action: Modification/Adjustment
• Type of Report: Initial
• Report Date (Section B): 11/13/2025

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: SMARTPATH TO DSTREAM FOR 1.5T
• Device Catalogue Number: 782146
• 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: 10/28/2025
• Initial Report FDA Received Date: 11/13/2025
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 2023-PD-MR-013
• Patient Sequence Number: 1
• Patient Sex: Unknown