ATELLICA SOLUTION ATELLICA CH 930 11067000

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2020-03-26 for ATELLICA SOLUTION ATELLICA CH 930 11067000 manufactured by Siemens Healthcare Diagnostics Inc..

MAUDE Entry Details

Report Number2432235-2020-00250
MDR Report Key9883577
Report SourceFOREIGN,HEALTH PROFESSIONAL,U
Date Received2020-03-26
Date of Report2020-03-26
Date of Event2020-02-26
Date Mfgr Received2020-03-06
Date Added to Maude2020-03-26
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 ContactKARL AEBIG
Manufacturer Street511 BENEDICT AVE
Manufacturer CityTARRYTOWN, NY
Manufacturer CountryUS
Manufacturer Phone5243102
Manufacturer G1SIEMENS HEALTHCARE DIAGNOSTICS INC.
Manufacturer Street62 FLANDERS BARTLEY RD REGISTRATION #: 2247117
Manufacturer CityFLANDERS, NJ
Manufacturer CountryUS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameATELLICA SOLUTION
Generic NameATELLICA SOLUTION
Product CodeJJE
Date Received2020-03-26
Model NumberATELLICA CH 930
Catalog Number11067000
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerSIEMENS HEALTHCARE DIAGNOSTICS INC.
Manufacturer Address511 BENEDICT AVE TARRYTOWN, NY US


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-26

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