MAUDE Adverse Event Report: PHILIPS 3T ACHIEVA TX

Model Number ACHIEVA TX 3T

Device Problem Insufficient Information (3190)

Patient Problems Burn(s) (1757); Erythema (1840); Pain (1994); Burning Sensation (2146)

Event Date 11/20/2017

Event Type  Injury  

Event Description

The pt was having an mri of the brain, cervical and thoracic spine w/wo contrast.It was performed on a 3t philips achieva tx unit.The nv 16 channel head coil and 15 channel spine coil was used together.The pt called back the next day to state that there was a quarter size spot on the back of her head that was burned from the mri scan.The pt also stated that the location of the burn was not on the back of the head where the head was rested on the coil, but more towards the crown of the head.The pt also stated that the last couple of scans after the contrast was given that spot started hurting really bad (feeling the burning pain).The pt did not say anything to the technologist thinking that it was a symptom from the ms.The family looked at the burn area at home and confirmed that it was a size of a quarter.F/u call to the pt: the pt had the burning sensation for about 2 days and everything is fine now.Redness and pain are gone.

• Brand Name: 3T ACHIEVA TX
• Type of Device: 3T ACHIEVA TX
• Manufacturer (Section D): PHILIPS
• MDR Report Key: 7074937
• MDR Text Key: 93660291
• Report Number: MW5073673
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ACHIEVA TX 3T
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 44 YR
• Patient Weight: 59