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

Model Number MR 7700

Device Problem Insufficient Information (3190)

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

Event Date 07/19/2023

Event Type  malfunction  

Event Description

Philips received a report of a gradient coil failure leading to burning smell and visual damage.

Manufacturer Narrative

Philips has started an investigation, a follow up report will be submitted after this investigation.

• Brand Name: MR 7700
• Type of Device: 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
• MDR Text Key: 321928316
• Report Number: 3003768277-2023-04632
• Device Sequence Number: 1
• Product Code: LNH
• UDI-Device Identifier: 00884838104112
• UDI-Public: 00884838104112
• Combination Product (y/n): N
• Reporter Country Code: TH
• PMA/PMN Number: K223442
• 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: 08/25/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MR 7700
• Device Catalogue Number: 782120
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/19/2023
• 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