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

Model Number 781296

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Full thickness (Third Degree) Burn (2696)

Event Date 03/25/2021

Event Type  Injury  

Event Description

Philips received a report on a heating incident on an achieva 1.5t mr system.A male patient was positioned feet first prone to undergo a kidney examination with the body and flex m coil.During the examination burns appeared on both feet of the patient.The burn on the left foot was 3rd degree and required medical intervention.

• 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
• Manufacturer (Section G): PHILIPS ELECTRONICS NEDERLAND B.V.; veenpluis 6; best 5684 PC; NL 5684 PC
• Manufacturer Contact: dusty leppert ; 222 jacobs st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 11655739
• MDR Text Key: 245104232
• Report Number: 3003768277-2021-10007
• Device Sequence Number: 1
• Product Code: LNH
• UDI-Device Identifier: 00884838004108
• UDI-Public: 884838004108
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K063559
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• 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: 04/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 781296
• Device Catalogue Number: 781296
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 03/26/2021
• Date Manufacturer Received: 03/26/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 19 MO
• Patient Weight: 9