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

Model Number ACHIEVA 3.0 T

Device Problems Insufficient Information (3190); Appropriate Term/Code Not Available (3191)

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

Event Date 10/09/2023

Event Type  malfunction  

Event Description

Philips received a report that a 3rd party ups/power stabilizer caught fire and damaged the mr system.

Manufacturer Narrative

Philips has started an investigation, a follow up will be sent once completed.

Manufacturer Narrative

The described issue was linked to a 3rd party automatic voltage regulator (avr) from supplier: swof (type uk50n, manufacturer jinghong electrical), which was used in combination with an achieva 3.0t philips magnetic resonance imaging device (6nc: 781177).The mr device did not contribute to this issue the event resulted in a burned connection block at the input of the automatic voltage regulator (avr).The incident was limited to this connection block and did not propagate.The quality of the used components likely limited the propagation (e.G., flammability rating).The likely cause of the event (i.E., overheated/damaged connection block) was a bad connection.This bad connection can be a result of an initial mistake during installation (missed torqueing of the connector) or that the connection did degenerate during the usage, for instance as result of thermal cycles.Or a combination of both.The input and the output cables were not installed by philips, but by the supplier of the avr.

• Brand Name: ACHIEVA 3.0 T
• 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: 17910903
• MDR Text Key: 325359349
• Report Number: 3003768277-2023-05545
• Device Sequence Number: 1
• Product Code: LNH
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K043147
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ACHIEVA 3.0 T
• Device Catalogue Number: 781177
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/11/2008
• 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