SENSIS VIBE HEMO 11007641

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,user facility report with the FDA on 2020-03-13 for SENSIS VIBE HEMO 11007641 manufactured by Siemens Healthcare Gmbh- At.

MAUDE Entry Details

Report Number3004977335-2020-21205
MDR Report Key9828974
Report SourceFOREIGN,USER FACILITY
Date Received2020-03-13
Date of Report2020-02-26
Date of Event2020-02-26
Date Mfgr Received2020-02-26
Date Added to Maude2020-03-13
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 ContactMEREDITH ADAMS
Manufacturer Street40 LIBERTY BLVD. 65-1A
Manufacturer CityMALVERN, PA
Manufacturer CountryUS
Manufacturer Phone4486461
Manufacturer G1SIEMENS HEALTHCARE GMBH- AT
Manufacturer StreetSIEMENSSTRASSE 1
Manufacturer CityFORCHHEIM, GERMANY 91301
Manufacturer CountryGM
Manufacturer Postal Code91301
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSENSIS VIBE HEMO
Generic NameCOMPUTER, DIAGNOSTIC, PROGRAMMABLE
Product CodeDQK
Date Received2020-03-13
Model Number11007641
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerSIEMENS HEALTHCARE GMBH- AT
Manufacturer AddressSIEMENSSTRASSE 1 FORCHHEIM, GERMANY 91301 GM 91301


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-13

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