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

Patient Problem Superficial (First Degree) Burn (2685)

Event Date 08/17/2023

Event Type  Injury  

Event Description

Patient underwent 2 sequences in appendix mri with array body coil on with ekg leads left on.It was discovered immediately and removed to finish the 7 minute scan.A dime sized lunar moon shape burn on right upper chest appeared about 12 hours later.No pain or issues for patient.History of staphylococcus scalded skin syndrome.Unsure 100% if caused from mri, but followed up and ensured mri safety is number one priority.Final checks and visual inspections now demonstrated heavily prior to scans.

• Brand Name: PHILIPS ACHIEVA 1.5T
• Type of Device: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
• MDR Report Key: 17755571
• MDR Text Key: 323624515
• Report Number: MW5145673
• Device Sequence Number: 1
• Product Code: LNH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 09/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 10 YR
• Patient Sex: Male
• Patient Weight: 42 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White