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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON DUAL HEATED DUAL DRAIN; ADULT BREATHING CIRCUIT
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TELEFLEX MEDICAL HUDSON DUAL HEATED DUAL DRAIN; ADULT BREATHING CIRCUIT Back to Search Results
Catalog Number 880-36KIT
Device Problem Melted (1385)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/01/2015
Event Type  malfunction  
Event Description
The customer alleges that the circuit wire on version 1 of iso-gard circuit melted the circuit.There was a volume loss through the melt point which did have an effect on the pt's end tidal co2 reading.The issue was corrected when the circuit was changed.There are no reports of pt injury or harm.
 
Manufacturer Narrative
(b)(4).The device sample was received by the manufacturer, but the investigation is incomplete at the time of this report.A dhr review could not be conducted since the lot number was not provided.
 
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Brand Name
HUDSON DUAL HEATED DUAL DRAIN
Type of Device
ADULT BREATHING CIRCUIT
Manufacturer (Section D)
TELEFLEX MEDICAL
research tringle park NC
Manufacturer (Section G)
TELEFLEX MEDICAL
parque industrial finsa
nuevo laredo, tamaulipas 8827 5
MX   88275
Manufacturer Contact
margie burton, rn
3015 carrington mill blvd
morrisville, NC 27560
9194334965
MDR Report Key4697509
MDR Text Key5648502
Report Number3004365956-2015-00119
Device Sequence Number1
Product Code CAG
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 03/23/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/15/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number880-36KIT
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer03/31/2015
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/23/2015
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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