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

Model Number	INGENIA 1.5T
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Partial thickness (Second Degree) Burn (2694)
Date of Event	11/16/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Philips received a repot on a heating incident.Patient claims burn from anterior coil during an mr examination.
Additional 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
• Common Device Name: 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
• Report Number: 3003768277-2022-01173
• Device Sequence Number: 17773510
• Product Code: LNH
• UDI-Device Identifier: 00884838099715
• UDI-Public: 00884838099715
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K183063
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial 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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/16/2022
• Supplement Date Received by Manufacturer: 11/16/2022
• Initial Report FDA Received Date: 11/23/2022
• Supplement Report FDA Received Date: 12/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Weight: 99 KG