FM-15UA-OH

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2012-12-03 for FM-15UA-OH manufactured by Precision Medical, Inc..

Event Text Entries

[3104865] .
Patient Sequence No: 1, Text Type: D, B5


[10467133] In conclusion this error appears not to be fault of the device, but of the care giver. The immediate solution would be training and vigilance, with long term, a standard correction, to the air flow meters and cannulas, forced across the industry by the fda and the compressed gas association.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2523148-2012-00004
MDR Report Key2897566
Report Source06
Date Received2012-12-03
Date Reported to FDA2012-09-01
Date Mfgr Received2012-05-11
Date Added to Maude2013-01-23
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactJIM PARKR
Manufacturer Street300 HELD DR.
Manufacturer CityNORTHAMPTON PA 18067
Manufacturer CountryUS
Manufacturer Postal18067
Manufacturer Phone6102626090
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Generic NameFLOW METER, OXYGEN
Product CodeCCL
Date Received2012-12-03
Catalog NumberFM-15UA-OH
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerPRECISION MEDICAL, INC.
Manufacturer Address300 HELD DR. NORTHAMPTON PA 18067 US 18067


Patients

Patient NumberTreatmentOutcomeDate
10 2012-12-03

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