PICCO MONITORING KIT PV8115

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,user faci report with the FDA on 2019-07-03 for PICCO MONITORING KIT PV8115 manufactured by Pulsion Medical Systems Se.

MAUDE Entry Details

Report Number3003263092-2019-00010
MDR Report Key8757306
Report SourceDISTRIBUTOR,FOREIGN,USER FACI
Date Received2019-07-03
Date of Report2019-07-26
Date of Event2019-04-12
Date Mfgr Received2019-06-12
Date Added to Maude2019-07-03
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 StreetHANS-RIEDL-STRASSE 17
Manufacturer CityFELDKIRCHEN
Manufacturer CountryUS
Manufacturer G1PULSION MEDICAL SYSTEMS SE
Manufacturer StreetHANS-RIEDL-STRASSE 17
Manufacturer CityFELDKIRCHEN
Manufacturer CountryUS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePICCO MONITORING KIT
Generic NamePROBE, THERMODILUTION
Product CodeKRB
Date Received2019-07-03
Catalog NumberPV8115
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerPULSION MEDICAL SYSTEMS SE
Manufacturer AddressHANS-RIEDL-STRASSE 17 FELDKIRCHEN US


Patients

Patient NumberTreatmentOutcomeDate
10 2019-07-03

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