MAUDE Adverse Event Report: PHILIPS ELECTRONICS NEDERLAND B.V. 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 11/14/2022

Event Type  Injury  

Event Description

Philips received a report that a patient sustained a 2nd degree burn with skin damage after a lumbar spin examination.

Manufacturer Narrative

Conclusion.Based on the available information, there is no indication of a malfunction of the mr system or coil used that could have contributed to the incident.The observed reddening and skin damage can be explained by close or direct contact between the patient and the bore wall.No padding was used to prevent this.Contributing factors: the thermoregulation of obese and hypertensive patients is known to be impaired.The risk of rf energy-related injuries is higher in patients with impaired thermoregulation.Several scans with high sar values (>2 w/kg) were executed.High sar scans are a bigger challenge for the cool down mechanism than low sar scans.The total administered specific energy dose of 3.7 kj/kg is very high for a patient with impaired thermoregulation.The instructions for use advises to avoid sed >3.0 kj/kg, preferably keep sed <2.0 kj/kg for those patients.

• 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: 16193690
• MDR Text Key: 307562063
• Report Number: 3003768277-2023-00340
• Device Sequence Number: 1
• Product Code: LNH
• UDI-Device Identifier: 00884838009820
• UDI-Public: 884838009820
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K110151
• 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: 01/18/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: INGENIA 1.5T
• Device Catalogue Number: 781396
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/10/2023
• 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: 162 KG