MAUDE Adverse Event Report: PHILIPS ELECTRONICS LTD PHILIPS INTERA 1.5T; SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING

Model Number 30030

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Blister (4537)

Event Date 03/14/2022

Event Type  Injury  

Event Description

Patient reports feeling a very warm sensation on inner thighs during and after mri.After, rn discovered that patient had developed bilateral blisters on inner thighs.Mri technologist indicates that had she performed the 3 ordered exams separately, scan time would have been at least 2 hours.Mri technologist indicates patient was "skinny" and recalls that the legs did not touch.Fda safety report id # (b)(4).

• Brand Name: PHILIPS INTERA 1.5T
• Type of Device: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): PHILIPS ELECTRONICS LTD
• MDR Report Key: 13887687
• MDR Text Key: 287928720
• Report Number: MW5108490
• 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: Pharmacist
• Type of Report: Initial
• Report Date: 03/22/2022

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
• Device Operator: Health Professional
• Device Model Number: 30030
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/23/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other