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

Model Number SMARTPATH TO DSTREAM FOR 1.5T

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

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

Event Date 10/08/2022

Event Type  Injury  

Event Description

Philips received a report on a heating incident.Patient got a burn in abdomen and rf burn.

Manufacturer Narrative

Conclusion: there is no indication of a malfunction of the mr system or coils used that could have contributed to the incident.The observed blistering can be explained by the presence of the metallic fibers in the clothing as the patient was wearing silk clothing which contained metallic fibers which subsequently heated up under the influence of the rf energy.

• Brand Name: ACHIEVA 1.5T DSTREAM
• Type of Device: ACHIEVA 1.5T DSTREAM
• 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: 15595271
• MDR Text Key: 301735220
• Report Number: 3003768277-2022-00499
• Device Sequence Number: 1
• Product Code: LNH
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K063559
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SMARTPATH TO DSTREAM FOR 1.5T
• Device Catalogue Number: 781260
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/08/2022
• Initial Date FDA Received: 10/13/2022
• Supplement Dates Manufacturer Received: 10/08/2022
• Supplement Dates FDA Received: 11/28/2022
• 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): Other
• Patient Age: 45 YR
• Patient Sex: Male
• Patient Weight: 60 KG