SMARTVIEW SMARTVIEW PSTN

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-26 for SMARTVIEW SMARTVIEW PSTN manufactured by Sorin Group Italia S.r.l. - Crm Facility.

Event Text Entries

[139986826] Reportedly, the status led of the subject home monitor remained red during the pairing process and the process could not be completed.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1000165971-2019-00160
MDR Report Key8450944
Date Received2019-03-26
Date of Report2019-07-05
Date of Event2018-11-29
Date Facility Aware2019-03-06
Date Mfgr Received2019-06-24
Date Added to Maude2019-03-26
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactELODIE VINCENT
Manufacturer StreetPARC D'AFFAIRES NOVEOS 4 AVENUE R .
Manufacturer CityCLAMART 92140
Manufacturer CountryFR
Manufacturer Postal92140
Manufacturer Phone0146013665
Manufacturer G1EOLANE BLD J. BAPTISTE COLBERT 49520 COMBREE FRANCE
Manufacturer StreetPARC D'AFFAIRES NOVEOS 4 AVENUE R .
Manufacturer CityCLAMART 92140
Manufacturer CountryFR
Manufacturer Postal Code92140
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameSMARTVIEW
Generic NameUNKNOWN
Product CodeOSR
Date Received2019-03-26
Model NumberSMARTVIEW PSTN
Catalog NumberSMARTVIEW PSTN
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerSORIN GROUP ITALIA S.R.L. - CRM FACILITY
Manufacturer AddressPARC D'AFFAIRES NOVEOS 4 AVENUE R?AUMUR . CLAMART 92140 FR 92140


Patients

Patient NumberTreatmentOutcomeDate
10 2019-03-26

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