SIGNA PIONEER

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-11-07 for SIGNA PIONEER manufactured by Ge Medical Systems, Llc.

MAUDE Entry Details

Report Number2183553-2019-00027
MDR Report Key9293064
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2019-11-07
Date of Report2019-11-07
Date of Event2019-10-10
Date Mfgr Received2019-10-13
Device Manufacturer Date2016-12-19
Date Added to Maude2019-11-07
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactJACQUI BUDDE
Manufacturer Street3200 N. GRANDVIEW BLVD.
Manufacturer CityWAUKESHA WI
Manufacturer CountryUS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSIGNA PIONEER
Generic NameNUCLEAR MAGNETIC RESONANCE IMAGING
Product CodeLNH
Date Received2019-11-07
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerGE MEDICAL SYSTEMS, LLC
Manufacturer Address3200 N GRANDVIEW BLVD. WAUKESHA, WI 53188 US 53188


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2019-11-07

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