MAUDE Adverse Event Report: PHILIPS HEALTHCARE INTERA 1.5T POWER/PULSAR; SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING

Model Number 781105

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

Patient Problem Full thickness (Third Degree) Burn (2696)

Event Date 04/16/2019

Event Type  Injury  

Manufacturer Narrative

The investigation is ongoing on this event.When the investigation is completed a follow up will be sent to the fda.

Event Description

Philips received a report from a customer related to a patient heating incident with an intera1.5t mr system.A patient was scanned for an mri examination.After the examination, a 3rd degree burn developed on the back side of the right leg of the patient.

Manufacturer Narrative

Based on the provided information and tests performed on site, there is no indication of a malfunction of the mri system that contributed to the injury.The shape and place of the injury corresponds with the rim of the posterior coil element that was connected, but not used during scanning.It is concluded that the posterior element of the synergy head/neck coil contributed to the injury.The posterior element shows physical damage and should not have been used for scanning.Possible contributing factors are: several scans with high sar values (> 2 w/kg) in combination with a long total examination time.This lead to a high rf energy dose for the patient that increases the risk of rf energy related injuries.The positioning of the foot in the tilted synergy head/neck coil with the posterior coil element connected.The rim of the posterior coil element has caused pressure on the lower leg at the place of the injury and reduced the local blood flow.

• Brand Name: INTERA 1.5T POWER/PULSAR
• Type of Device: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): PHILIPS HEALTHCARE; veenpluis 4-6; p.o. box 10.000; best 5680 DA; NL 5680 DA
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: dusty leppert ; veenpluis 4-6; p.o. box 10.000; best 5680 -DA ; NL 5680 DA
• MDR Report Key: 8662290
• MDR Text Key: 146781861
• Report Number: 3003768277-2019-00045
• Device Sequence Number: 1
• Product Code: LNH
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K001796
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 781105
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/10/2019
• Initial Date FDA Received: 06/03/2019
• Supplement Dates Manufacturer Received: 05/10/2019
• Supplement Dates FDA Received: 07/29/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/12/2003
• 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: 32 YR
• Patient Weight: 78