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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONCHASMART 22MM DUAL LIMB HEATED CIRCUIT KIT; HUMIDIFIER, RESPIRATORY GAS, (
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CONCHASMART 22MM DUAL LIMB HEATED CIRCUIT KIT; HUMIDIFIER, RESPIRATORY GAS, ( Back to Search Results
Catalog Number 870-35KIT
Medical Device Problem Code Infusion or Flow Problem (2964)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 06/04/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
(b)(4).Medwatch report# (b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.Without the device to evaluate, the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.If the sample becomes available at a later date a follow up report will be submitted with investigation results.
 
Event or Problem Description
Medwatch complaint received reports the following: ventilator circuit collecting large amounts of condensation despite heater wire circuit and q4 dumping and double wall expiratory filter, water got into the vent and caused several alarms.Patient continued to be ventilated but vent had to be changed out.Additional information received from the customer reports the issue is excessive condensation requiring dumping or suctioning from the circuit.The customer reported this has been an issue since (b)(6) 2019.The customer also reported "some issues of the patient having condensation go down the endotracheal tube or trach when being repositioned," but they have not had any patient injury or harm.
 
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Brand Name
CONCHASMART 22MM DUAL LIMB HEATED CIRCUIT KIT
Common Device Name
HUMIDIFIER, RESPIRATORY GAS, (
MDR Report Key9969125
Report Number3004365956-2020-00100
Device Sequence Number2914114
Product Code BTT
Combination Product (Y/N)N
Initial Reporter StateMS
Initial Reporter CountryUS
PMA/510(K) Number
K131912
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source other,user facility
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 03/31/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device No Information
Device Catalogue Number870-35KIT
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/31/2020
Initial Report FDA Received Date04/16/2020
Was Device Evaluated by Manufacturer? (Y/N) Device Not Returned to Manufacturer
Is the Device Labeled for Single Use? (Y/N) Yes
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Usage of Device Initial
Patient Sequence Number1
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