E70 COUGH ASSIST 1098159

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 2019-06-12 for E70 COUGH ASSIST 1098159 manufactured by Respironics, Inc..

MAUDE Entry Details

Report Number1040777-2019-00027
MDR Report Key8692002
Report SourceFOREIGN,USER FACILITY
Date Received2019-06-12
Date of Report2019-05-21
Date of Event2019-05-03
Date Mfgr Received2019-09-29
Device Manufacturer Date2015-01-09
Date Added to Maude2019-06-12
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 NameE70 COUGH ASSIST
Generic NamePERCUSSOR, POWERED-ELECTRIC
Product CodeBYI
Date Received2019-06-12
Model Number1098159
Catalog Number1098159
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerRESPIRONICS, INC.
Manufacturer Address175 CHASTIAN MEADOWS COURT KENNESAW GA 301443724 US 301443724


Patients

Patient NumberTreatmentOutcomeDate
10 2019-06-12

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