MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. ACHIEVA 3.0T TX; SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING

Model Number ACHIEVA 3.0T

Device Problem Insufficient Information (3190)

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

Event Date 07/11/2023

Event Type  Injury  

Event Description

This complaint was reviewed.The customer alleged that during an abdomen prostate scanning, the patient felt heating from scanning with mri torso xl coil.7 days post scanning the patient reported an approximately 4 inch long x.4 inch in diameter blistered area on abdomen, right of umbilicus.This is considered a serious injury.Based on the available information, this issue has been determined to be a reportable event.

• Brand Name: ACHIEVA 3.0T TX
• Type of Device: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.; veenpluis 6; best 5684 PC; NL 5684 PC
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.; veenpluis 6; best 5684 PC; NL 5684 PC
• Manufacturer Contact: dusty leppert ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 17421447
• MDR Text Key: 320016844
• Report Number: 3003768277-2023-04264
• Device Sequence Number: 1
• Product Code: LNH
• UDI-Device Identifier: 00884838004139
• UDI-Public: 884838004139
• Combination Product (y/n): N
• Reporter Country Code: TC
• PMA/PMN Number: K063559
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ACHIEVA 3.0T
• Device Catalogue Number: 781278
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/20/2023
• Was Device Evaluated by Manufacturer?: No
• 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: 68 YR
• Patient Sex: Male
• Patient Weight: 92 KG