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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARESTREAM HEALTH, INC. DRX REVOLUTION MOBILE X-RAY SYSTEM
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CARESTREAM HEALTH, INC. DRX REVOLUTION MOBILE X-RAY SYSTEM Back to Search Results
Model Number DRXR-1
Device Problem Use of Device Problem (1670)
Patient Problem Arthralgia (2355)
Event Date 03/24/2014
Event Type  Injury  
Event Description
A revolution system lurched backwards when the technician was trying to go forward and it ran over the technician's foot.
 
Manufacturer Narrative
Based upon the field engineer's evaluation of the equipment at the customer site, the device was performing to specification.This issue is related to user error where carestream believes the user may not have been using the device according to the instructions.
 
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Brand Name
DRX REVOLUTION MOBILE X-RAY SYSTEM
Type of Device
DRX REVOLUTION
Manufacturer (Section D)
CARESTREAM HEALTH, INC.
rochester NY
Manufacturer (Section G)
CARESTREAM HEALTH, INC.
1049 west ridge road
rochester NY 14615
Manufacturer Contact
michael callery, mgr
150 verona st.,
rochester, NY 14608
5856278230
MDR Report Key3767227
MDR Text Key17614690
Report Number1317307-2014-00003
Device Sequence Number1
Product Code IZL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K120062
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 03/31/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberDRXR-1
Device Catalogue Number1019397
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/25/2014
Initial Date FDA Received04/01/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/01/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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