OPTIMA XR200 5555000

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2019-07-29 for OPTIMA XR200 5555000 manufactured by Ge Medical Systems, Llc.

MAUDE Entry Details

Report Number2126677-2019-00009
MDR Report Key8837854
Report SourceHEALTH PROFESSIONAL,USER FACI
Date Received2019-07-29
Date of Report2019-08-15
Date of Event2019-05-18
Date Mfgr Received2019-07-31
Device Manufacturer Date1970-01-01
Date Added to Maude2019-07-29
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactSTEVEN WALCZAK
Manufacturer Street3000 NORTH GRANDVIEW BOULEVARD
Manufacturer CityWAUKESHA WI
Manufacturer CountryUS
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameOPTIMA XR200
Generic NameSYSTEM, X-RAY, MOBILE
Product CodeIZL
Date Received2019-07-29
Model Number5555000
Lot NumberNA
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerGE MEDICAL SYSTEMS, LLC
Manufacturer Address3000 NORTH GRANDVIEW BOULEVARD WAUKESHA, WI 53188 US 53188


Patients

Patient NumberTreatmentOutcomeDate
10 2019-07-29

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