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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARESTREAM HEALTH, INC. CARESTREAM DRX-MOBILE RETROFIT KIT SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)

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CARESTREAM HEALTH, INC. CARESTREAM DRX-MOBILE RETROFIT KIT SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER) Back to Search Results
Device Problem Radiation Output Problem (4026)
Patient Problem Radiation Exposure, Unintended (3164)
Event Date 09/04/2020
Event Type  malfunction  
Event Description
Exposure could not be made resulting in getting another machine resulting in possible re-exposure to patient.
 
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Brand NameCARESTREAM DRX-MOBILE RETROFIT KIT
Type of DeviceSOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)
Manufacturer (Section D)
CARESTREAM HEALTH, INC.
1049 west ridge road
rochester NY 14615
MDR Report Key10655620
MDR Text Key210613331
Report Number10655620
Device Sequence Number1
Product Code MQB
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 09/08/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/09/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/08/2020
Event Location No Information
Date Report to Manufacturer10/09/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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