MAUDE Adverse Event Report: PHILIPS ELECTRONICS NEDERLAND B.V. SMARTPATH TO DSTREAM FOR 1.5T; SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING

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	11/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cone rubber is detached was secured again 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 send to the customers informing them about this potential issue.A field correction is scheduled to be released in q4-2024.
Event or Problem Description
Philips received a report that the cone rubber is detached.This seal is used for protection, to avoid the patient from potentially contacting the sharp edges of the magnet covers.If this seal is loose it is likely that this could lead to serious injury.

• Brand Name: SMARTPATH TO DSTREAM FOR 1.5T
• 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: 20731625
• Report Number: 3003768277-2024-006656
• Device Sequence Number: 12997168
• Product Code: LNH
• UDI-Device Identifier: 00884838108691
• UDI-Public: (01)00884838108691
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• 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): 11/20/2024

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: 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: 11/15/2024
• Initial Report FDA Received Date: 11/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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