DRX-1 TRANSPORTABLE SYSTEM

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-10-02 for DRX-1 TRANSPORTABLE SYSTEM manufactured by Carestream Health, Inc..

MAUDE Entry Details

Report Number9144771
MDR Report Key9144771
Date Received2019-10-02
Date of Report2019-09-24
Date of Event2019-09-18
Report Date2019-09-24
Date Reported to FDA2019-09-24
Date Reported to Mfgr2019-10-02
Date Added to Maude2019-10-02
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag0
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationBIOMEDICAL ENGINEER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameDRX-1 TRANSPORTABLE SYSTEM
Generic NameSOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)
Product CodeMQB
Date Received2019-10-02
Returned To Mfg2019-09-18
Model NumberDRX-1
Device AvailabilityR
Device Age8 MO
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerCARESTREAM HEALTH, INC.
Manufacturer Address1049 WEST RIDGE ROAD ROCHESTER NY 14615 US 14615


Patients

Patient NumberTreatmentOutcomeDate
10 2019-10-02

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