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

Model Number INGENIA 1.5T R5 BASED

Device Problem Improper or Incorrect Procedure or Method (2017)

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

Event Date 08/09/2023

Event Type  Injury  

Event Description

Philips received a report that a patient suffered large, 3cm, blisters on both knees during a pelvic examination.

Manufacturer Narrative

There is no indication of a malfunction of the mr system or coil used that could have contributed to the incident.It is concluded that the injury was the result of direct contact between the knees which allowed an rf loop to form.This caused a skin-to-skin contact rf burn.No padding was used to prevent this contact from occurring.This incident is considered a user error that could have been prevented if the instructions for use had been observed.

• Brand Name: INGENIA 1.5T
• Type of Device: INGENIA 1.5T
• 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: 17601783
• MDR Text Key: 321711596
• Report Number: 3003768277-2023-04585
• Device Sequence Number: 1
• Product Code: LNH
• UDI-Device Identifier: 00884838055322
• UDI-Public: 884838055322
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K163116
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: INGENIA 1.5T R5 BASED
• Device Catalogue Number: 781341
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/16/2023
• 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: 64 YR
• Patient Sex: Male
• Patient Weight: 82 KG