HUDSON ISO-GARD HEPA LIGHT,CLEAN 28022

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 2018-08-28 for HUDSON ISO-GARD HEPA LIGHT,CLEAN 28022 manufactured by Teleflex Medical.

Event Text Entries

[118548963] (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[118548964] Customer complaint alleges "filter in use on expiratory side of vent (servo-i) using 880-36kit circuit. Filter works fine for a few hours and then restricts flow setting off vent alarm. (cont. ) clinician said it acts like a one way valve is closing inside filter. " it was reported there was no patient injury or consequence. Patient condition reported as "fine".
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number8040412-2018-00224
MDR Report Key7822777
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2018-08-28
Date of Report2018-08-10
Date of Event2018-08-03
Date Mfgr Received2018-10-05
Date Added to Maude2018-08-28
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 ISO-GARD HEPA LIGHT,CLEAN
Generic NameFILTER, BACTERIAL, BREATHING-C
Product CodeCAH
Date Received2018-08-28
Catalog Number28022
Lot NumberUNKNOWN
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerTELEFLEX MEDICAL
Manufacturer AddressPERAK, WEST MALAYSIA


Patients

Patient NumberTreatmentOutcomeDate
10 2018-08-28

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