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

Model Number 781295

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Skin Irritation (2076)

Event Date 08/09/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Philips received a report from a customer related to a patient heating incident with an intera 1.5t mr system.A patient was scanned for an mri examination.After the examination a large area with skin reddening (15 cm) was observed on the patient's right arm and elbow, with blistering.

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.The reddening and subsequent blistering that was observed on the patient's arm was caused by direct contact with the cable of the head coil.No padding was used and it was reported that no distance could be kept due to the patient's size.Contributing factors observed are: the patient was obese.The thermoregulation of obese patients is known to be impaired.The risk of rf energy-related injuries is higher in patients with impaired thermoregulation.Humidity of the examination room.The total administered whole body rf dose.

• 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
• MDR Report Key: 7860215
• MDR Text Key: 119684284
• Report Number: 3003768277-2018-00068
• Device Sequence Number: 1
• Product Code: LNH
• Combination Product (y/n): N
• PMA/PMN Number: K052013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2018
• 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: 08/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 44 YR
• Patient Weight: 90