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

Model Number 781295

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

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

Event Date 11/27/2019

Event Type  Injury  

Manufacturer Narrative

Based on the provided information and test performed on site there is no indication of a malfunction of the mr system or coil used that contributed to the event.The injury between the patient¿s thighs is consistent with heating injuries caused by skin-to-skin contact.In this case no padding was used to ensure sufficient distance between the patient¿s thighs.When the patient reported heating during the examination, a sheet was placed in between the thighs.A sheet is not considered an appropriate way to create distance, nor is it an effective insulator.Contributing factors observed are: 5 scans were administered on high sar.The patient was covered with a sheet/blanket.

Event Description

Philips received a report from a customer related to a patient heating incident (blistering between the thighs) with a body coil on an intera 1.5t mr system.

• Brand Name: INTERA 1.5T PULSAR NEW
• 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: 9472884
• MDR Text Key: 170875986
• Report Number: 3003768277-2019-00101
• Device Sequence Number: 1
• Product Code: LNH
• Combination Product (y/n): N
• Reporter Country Code: AR
• PMA/PMN Number: K052013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 781295
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/28/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/03/2011
• 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: 39 YR
• Patient Weight: 80