EASYPULSE5

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-05-01 for EASYPULSE5 manufactured by Unk.

Event Text Entries

[20794761] I have been using an easypulse 5 pulse setting flow meter for the best part of 2 years. On a persistent, daily, basis, the regulator, even when enclosed in a carrying bag, would seldom be found to register the prescribed 2 liter flow, often either showing off or 2 l continuous flow which, in either case, i would note secondary to progressive dyspnea. The worst case being with a 2l continuous flow depleting a new m6 2000psi bottle in less than 2 hours. I was caught without a reserve, became nearly unconscious, when my son quickly drove me to a nearby police station, who subsequently radioed for an ambulance. Receiving oxygen, i quickly recovered without sequelae. I was given a new valve by my respiratory supply carrier at least the third with the same complaints, and was told this was a brand new regulator and would not malfunction. That same day, the same problems occurred multiple times. I have always followed the instructions of turning the valve off when not in use, with a key chained to the carrying bag. I think there is an inherent flaw in the design, with not enough of a detain at the prescribed flow rate. As a consequence of these problems, i am using far too much oxygen and am constantly concerned about the ready availability of the oxygen i need to survive, thank you.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5025275
MDR Report Key2561600
Date Received2012-05-01
Date of Report2012-05-01
Date of Event2012-05-01
Date Added to Maude2012-05-09
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameEASYPULSE5
Generic NamePULSED OXYGEN FLOW REGULATOR
Product CodeNFB
Date Received2012-05-01
Lot NumberSN624640
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Sequence No1
Device Event Key0
ManufacturerUNK


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2012-05-01

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