HUDSON BACTERIAL/VIRAL FILTER 1605

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-03-24 for HUDSON BACTERIAL/VIRAL FILTER 1605 manufactured by Teleflex Medical.

Event Text Entries

[139701920] (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[139701921] Customer complaint alleges "there must be a leak in the filters because our ventilators would not pass the leak test with the inspiratory filter inline, but would pass without". Alleged issue reported detected during functional testing of the ventilator set up prior to a patient use. No patient injury or complication was reported.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number8040412-2019-00089
MDR Report Key8446686
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2019-03-24
Date of Report2019-03-19
Date of Event2019-03-18
Date Mfgr Received2019-05-08
Date Added to Maude2019-03-24
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactKATHARINE TARPLEY
Manufacturer Street3015 CARRINGTON MILL BLVD
Manufacturer CityMORRISVILLE NC 27560
Manufacturer CountryUS
Manufacturer Postal27560
Manufacturer Phone9194334854
Manufacturer G1TELEFLEX MEDICAL
Manufacturer StreetPO BOX 28, KAMUNTING INDUSTRIAL ESTATE
Manufacturer CityPERAK, WEST MALAYSIA 34600
Manufacturer CountryMY
Manufacturer Postal Code34600
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameHUDSON BACTERIAL/VIRAL FILTER
Generic NameFILTER, BACTERIAL, BREATHING-C
Product CodeCAH
Date Received2019-03-24
Catalog Number1605
Lot Number201826
Device AvailabilityY
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerTELEFLEX MEDICAL
Manufacturer AddressPERAK, WEST MALAYSIA


Patients

Patient NumberTreatmentOutcomeDate
10 2019-03-24

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