HUDSON POCKETPEAK, PEAK FLOW METER, UNIVERSAL RA 1801

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 2014-03-25 for HUDSON POCKETPEAK, PEAK FLOW METER, UNIVERSAL RA 1801 manufactured by Teleflex.

Event Text Entries

[4499901] The complaint is reported as: the customer alleges that when the pt blows into the peak flow meter the blue indicator moves very easily. The pt barely breathes in to the meter and the blue indicator moves to the high end of the scale with very little pressure. The device was changed out for another one. No pt harm reported.
Patient Sequence No: 1, Text Type: D, B5


[11891211] The device sample was not returned for evaluation at the time of this report.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1044475-2014-00075
MDR Report Key3815848
Report Source06
Date Received2014-03-25
Date of Report2014-03-12
Date of Event2014-03-06
Date Mfgr Received2014-03-12
Date Added to Maude2014-06-11
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 FDA0
Event Location0
Manufacturer ContactMARGIE BURTON, RN
Manufacturer StreetP.O. BOX 12600
Manufacturer CityRESEARCH TRIANGLE PARK NC 27709
Manufacturer CountryUS
Manufacturer Postal27709
Manufacturer Phone9194334965
Manufacturer G1TELEFLEX
Manufacturer Street2917 WECK DR.
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameHUDSON POCKETPEAK, PEAK FLOW METER, UNIVERSAL RA
Generic NamePEAK FLOW METER (SPIROMETRY
Product CodeBZH
Date Received2014-03-25
Catalog Number1801
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerTELEFLEX
Manufacturer AddressRESEARCH TRIANGLE PARK NC 27709 US 27709


Patients

Patient NumberTreatmentOutcomeDate
10 2014-03-25

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