HUDSON HUMID VENT COMPACT S 19401

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2019-01-03 for HUDSON HUMID VENT COMPACT S 19401 manufactured by Teleflex Medical.

Event Text Entries

[132072164] (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[132072365] Customer complaint alleges "during mechanical ventilation, the filter positioned between the machine and the patient circuit broke. As a consequence there has been a lack of ventilation (continued) and dispersion of inhalation anaesthetics in the environment. " it was reported there was no injury to the patient. Patient condition reported as fine. There was no report of injury to staff.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number8040412-2019-00014
MDR Report Key8213556
Report SourceCOMPANY REPRESENTATIVE,DISTRI
Date Received2019-01-03
Date of Report2018-12-14
Date of Event2018-12-03
Date Mfgr Received2019-02-01
Device Manufacturer Date2018-07-01
Date Added to Maude2019-01-03
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
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 HUMID VENT COMPACT S
Generic NameFILTER, BACTERIAL BREATHING CIRCUIT
Product CodeCAH
Date Received2019-01-03
Catalog Number19401
Lot Number18GT13
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 2019-01-03

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