GIBECK ISO-GARD FILTER SMALL S, TETHERED CAP IPN043788 19512TN

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,user faci report with the FDA on 2020-01-02 for GIBECK ISO-GARD FILTER SMALL S, TETHERED CAP IPN043788 19512TN manufactured by Teleflex Medical Sdn. Bhd..

Event Text Entries

[173334137] (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[173334138] Customer reported a ventilated patient desaturated to 84% and tidal volume went down to 200. The filter was changed and the issue resolved. No further issues or injury to patient reported after filter was changed. Patient condition reported as "fine".
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number8040412-2020-00001
MDR Report Key9538673
Report SourceDISTRIBUTOR,FOREIGN,USER FACI
Date Received2020-01-02
Date of Report2019-12-11
Date of Event2019-12-10
Date Mfgr Received2020-01-28
Date Added to Maude2020-01-02
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 SDN. BHD.
Manufacturer StreetLOT NO : PT2577 JALEN PERUSAHAAN 4 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 NameGIBECK ISO-GARD FILTER SMALL S, TETHERED CAP
Generic NameBREATHING CIRCUIT BACTERIAL FILTER
Product CodeCAH
Date Received2020-01-02
Returned To Mfg2020-01-03
Model NumberIPN043788
Catalog Number19512TN
Lot Number201925
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerTELEFLEX MEDICAL SDN. BHD.
Manufacturer AddressPERAK, WEST MALAYSIA


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-01-02

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