MAUDE Adverse Event Report: PHILIPS ELECTRONICS NEDERLAND B.V. ACHIEVA 1.5T NEW

Model Number ACHIEVA 1.5T

Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/22/2020

Event Type  malfunction  

Event Description

Magnet quench after a fire in the vicinity of the examination room.

Event Description

Magnet quench after a fire in the vicinity of the examination room.

• Brand Name: ACHIEVA 1.5T NEW
• Type of Device: ACHIEVA 1.5T NEW
• Manufacturer (Section D): PHILIPS ELECTRONICS NEDERLAND B.V.; veenpluis 6; best 5684 PC; NL 5684 PC
• MDR Report Key: 9749763
• MDR Text Key: 184276118
• Report Number: 3003768277-2020-01001
• Device Sequence Number: 1
• Product Code: LNH
• UDI-Device Identifier: 00884838004108
• UDI-Public: 884838004108
• Combination Product (y/n): N
• PMA/PMN Number: K063559
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: ACHIEVA 1.5T
• Device Catalogue Number: 781296
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 01/26/2020
• Date Manufacturer Received: 01/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other