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

Model Number ACHIEVA 1.5T

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Date 06/02/2021

Event Type  Injury  

Event Description

Philips received a report on a heating incident on an achieva 1.5t mr system.

Event Description

Philips received a report on a heating incident on an achieva 1.5t mr system.

• 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: 12265999
• MDR Text Key: 264695410
• Report Number: 3003768277-2021-10037
• 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: 08/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ACHIEVA 1.5T
• Device Catalogue Number: 781296
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 07/06/2021
• Date Manufacturer Received: 07/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 56 YR
• Patient Weight: 65