MAUDE Adverse Event Report: PHILIPS ELECTRONICS NEDERLAND B.V. ACHIEVA 3.0T DSTREAM; SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING

Model Number SMARTPATH TO DSTREAM FOR XR AND 3.0T

Device Problem Electrical /Electronic Property Problem (1198)

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

Event Date 01/23/2024

Event Type  malfunction  

Manufacturer Narrative

Philips has started an investigation, a follow up report will be submitted once the investigation has been completed.

Event Description

Philips received a report on a gradient coil failure.Upon replacement of the coil burn marks were found on the inside and outside of the coil.In light of previous gradient coil failures and out of an abundance of caution, it was decided to report this malfunction.

• Brand Name: ACHIEVA 3.0T DSTREAM
• Type of Device: 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: 18776390
• MDR Text Key: 336741538
• Report Number: 3003768277-2024-01243
• Device Sequence Number: 1
• Product Code: LNH
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K043147
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SMARTPATH TO DSTREAM FOR XR AND 3.0T
• Device Catalogue Number: 781270
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/16/2024
• Was Device Evaluated by Manufacturer?: No
• 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