SIMPLYGO MINI OXYGEN CONCENTRATOR 1113602

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-11-13 for SIMPLYGO MINI OXYGEN CONCENTRATOR 1113602 manufactured by Respironics, Inc..

MAUDE Entry Details

Report Number1040777-2019-00046
MDR Report Key9315687
Report SourceCOMPANY REPRESENTATIVE
Date Received2019-11-13
Date of Report2019-11-05
Date of Event2019-11-05
Date Mfgr Received2019-11-05
Device Manufacturer Date2019-10-22
Date Added to Maude2019-11-13
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 ContactADAM PRICE
Manufacturer Street312 ALVIN DRIVE
Manufacturer CityNEW KENSINGTON PA 15068
Manufacturer CountryUS
Manufacturer Postal15068
Manufacturer Phone7243349303
Manufacturer G1RESPIRONICS, INC.
Manufacturer Street175 CHASTIAN MEADOWS COURT
Manufacturer CityKENNESAW GA 301443724
Manufacturer CountryUS
Manufacturer Postal Code301443724
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSIMPLYGO MINI OXYGEN CONCENTRATOR
Generic NameGENERATOR, OXYGEN, PORTABLE
Product CodeCAW
Date Received2019-11-13
Returned To Mfg2019-11-04
Model Number1113602
Catalog Number1113602
OperatorLAY USER/PATIENT
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerRESPIRONICS, INC.
Manufacturer Address175 CHASTIAN MEADOWS COURT KENNESAW GA 301443724 US 301443724


Patients

Patient NumberTreatmentOutcomeDate
10 2019-11-13

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.