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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS 3T ACHIEVA TX

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PHILIPS 3T ACHIEVA TX Back to Search Results
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.
 
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Brand Name3T ACHIEVA TX
Type of Device3T ACHIEVA TX
Manufacturer (Section D)
PHILIPS
MDR Report Key7074937
MDR Text Key93660291
Report NumberMW5073673
Device Sequence Number1
Product Code LNH
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
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 Received11/30/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberACHIEVA TX 3T
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 11/30/2017 Patient Sequence Number: 1
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