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

Model Number INGENIA 1.5T

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

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

Event Date 11/16/2022

Event Type  Injury  

Event Description

Philips received a repot on a heating incident.Patient claims burn from anterior coil during an mr examination.

Manufacturer Narrative

Philips has investigated the reported problem.Philips has completed a good faith effort to get further information regarding the sequence of events of the reported problem.There is no indication of a malfunction of the mr system or coil used that could have contributed to the incident.The observed blistering can be explained by the presence of the ecg electrodes that were left in place after the ct examination that was done before mr examination.The location of the burn marks corresponds with the location of the ecg electrodes.Philips is closing this complaint and this event will be included in the post market surveillance trend analysis.

• Brand Name: INGENIA
• 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 st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 15852349
• MDR Text Key: 304189542
• Report Number: 3003768277-2022-01173
• Device Sequence Number: 1
• Product Code: LNH
• UDI-Device Identifier: 00884838099715
• UDI-Public: 00884838099715
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K183063
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: 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: 11/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: INGENIA 1.5T
• Device Catalogue Number: 781315
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/16/2022
• 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: 68 YR
• Patient Sex: Female
• Patient Weight: 99 KG