OPTIMA XR200AMX

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-09-23 for OPTIMA XR200AMX manufactured by Ge Medical Systems, Llc.

MAUDE Entry Details

Report Number9103363
MDR Report Key9103363
Date Received2019-09-23
Date of Report2019-08-27
Date of Event2019-08-26
Report Date2019-08-27
Date Reported to FDA2019-08-27
Date Reported to Mfgr2019-09-23
Date Added to Maude2019-09-23
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameOPTIMA
Generic NameSYSTEM, X-RAY, MOBILE
Product CodeIZL
Date Received2019-09-23
Model NumberXR200AMX
OperatorHEALTH PROFESSIONAL
Device Availability*
Device Age1 DA
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerGE MEDICAL SYSTEMS, LLC
Manufacturer Address3000 N GRANDVIEW BLVD. WAUKESHA WI 53188 US 53188


Patients

Patient NumberTreatmentOutcomeDate
10 2019-09-23

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