MAUDE Adverse Event Report: PHILIPS ELECTRONICS NEDERLAND B.V. ACHIEVA 1.5T NEW; SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING

Model Number ACHIEVA 1.5T

Device Problem Improper or Incorrect Procedure or Method (2017)

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

Event Date 10/18/2023

Event Type  Injury  

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 reddening and blistering can be explained by direct contact between the right arm and the bore wall.No padding was used to prevent this from happening and the patient was not able to indicate a burning sensation due to being sedated for the duration of the examination, which lasted around 2 hours.Contributing factors in this case: 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 patient was sedated.The thermoregulation of sedated patients is known to be impaired.The risk of rf energy-related injuries is higher in patients with impaired thermoregulation.The thermoregulation of obese patients is known to be impaired.The risk of rf energy-related injuries is higher in patients with impaired thermoregulation.The total administered specific energy dose of 5.8 kj/kg far exceeded the recommended limit of 2.0 kj/kg for patients with impaired thermoregulation.

Event Description

Philips received a report that a patient suffered blistering on the arm during an mr examination whilst being sedated.

• Brand Name: ACHIEVA 1.5T NEW
• Type of Device: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• 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: 18167003
• MDR Text Key: 328480530
• Report Number: 3003768277-2023-06320
• Device Sequence Number: 1
• Product Code: LNH
• UDI-Device Identifier: 00884838004108
• UDI-Public: 884838004108
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ACHIEVA 1.5T
• Device Catalogue Number: 781296
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/23/2023
• 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: 28 YR
• Patient Sex: Female
• Patient Weight: 107