MAUDE Adverse Event Report: PHILIPS ELECTRONICS NEDERLAND B.V. ACHIEVA 1.5T NOVA; SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING

Model Number ACHIEVA 1.5T NOVA

Device Problems Improper or Incorrect Procedure or Method (2017); Insufficient Information (3190)

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

Event Date 10/06/2023

Event Type  Injury  

Event Description

Philips received a report that a patient suffered a large 2nd degree burn on her right knee during an mr examination of the right knee.

Manufacturer Narrative

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

Manufacturer Narrative

There is no indication of a system or coil malfunction that could have contribute to the incident.The reported injury can be explained by direct contact between the coil cable and the skin.There was no padding placed to prevent his contact causing rf coupling between the cable and the skin.Reference to the instructions for use: as per ifu ¿459801678013_ifu_p60_int_pnl_en-us_2020-04¿ page 352, the cables should be routed straight, and it should neither touch each other nor the patient.¿ there should be padding between the coil cables and patient.Page 64 refers warning to avoid direct contact of the patient¿s skin with the rf coil cable assembly which could result to burn.

• Brand Name: ACHIEVA 1.5T NOVA
• 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: 17912911
• MDR Text Key: 325399749
• Report Number: 3003768277-2023-05546
• Device Sequence Number: 1
• Product Code: LNH
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K052013
• 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,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?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ACHIEVA 1.5T NOVA
• Device Catalogue Number: 781196
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/07/2023
• 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
• Patient Outcome(s): Other
• Patient Age: 54 YR
• Patient Sex: Female
• Patient Weight: 90 KG