PULSION PULSIOCATH THERMODILUTION CATHETERS PV2015L20-A

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2020-02-17 for PULSION PULSIOCATH THERMODILUTION CATHETERS PV2015L20-A manufactured by Pulsion Medical Systems Se.

MAUDE Entry Details

Report Number3003263092-2020-00001
MDR Report Key9716692
Report SourceCOMPANY REPRESENTATIVE,DISTRI
Date Received2020-02-17
Date of Report2020-03-13
Date of Event2019-10-06
Date Mfgr Received2020-03-11
Device Manufacturer Date2018-10-01
Date Added to Maude2020-02-17
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 ContactMS. CHRISTINA CARLSOHN
Manufacturer StreetHANS-RIEDL-STRASSE 17
Manufacturer CityFELDKIRCHEN 85622
Manufacturer CountryGM
Manufacturer Postal85622
Manufacturer Phone0894599140
Manufacturer G1PULSION MEDICAL SYSTEMS SE
Manufacturer StreetHANS-RIEDL-STRASSE 17
Manufacturer CityFELDKIRCHEN 85622
Manufacturer CountryGM
Manufacturer Postal Code85622
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePULSION PULSIOCATH THERMODILUTION CATHETERS
Generic NamePROBE, THERMODILUTION
Product CodeKRB
Date Received2020-02-17
Model NumberPV2015L20-A
Catalog NumberPV2015L20-A
Lot Number660718
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 85622 GM 85622


Patients

Patient NumberTreatmentOutcomeDate
10 2020-02-17

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