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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: REVOLUTION ACT; COMPUTED TOMOGRAPHY X-RAY SYSTEM
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REVOLUTION ACT; COMPUTED TOMOGRAPHY X-RAY SYSTEM Back to Search Results
Model Number CSEC21
Device Problems Unintended System Motion (1430); Use of Device Problem (1670)
Patient Problem Laceration(s) (1946)
Event Type  Injury  
Manufacturer Narrative
Unique identifier: udi not required.Legal manufacturer: (b)(4).Ge healthcare's investigation is ongoing.A follow up report will be submitted when the investigation has been completed.Device evaluation anticipated, but not yet begun.
 
Event Description
It was reported that a patient received 20 stitches to treat an arm injury sustained while the table was exiting the bore.
 
Manufacturer Narrative
It was reported that when a patient was being scanned, their left arm was off the table while they were traveling out of the gantry bore.The arm was pinched and 20 stitches were administered to treat the injury.The cradle movement is controlled by a control panel on the gantry or a foot pedals on the table.The gantry has a collision sensor which detects a touch by objects at the top center of the bore.
 
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Brand Name
REVOLUTION ACT
Type of Device
COMPUTED TOMOGRAPHY X-RAY SYSTEM
MDR Report Key12135836
MDR Text Key260514428
Report Number9613445-2021-00002
Device Sequence Number1
Product Code JAK
Combination Product (y/n)N
PMA/PMN Number
K171013
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Type of Report Initial,Followup
Report Date 09/14/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/08/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberCSEC21
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received08/19/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/24/2021
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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