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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON UNIVERSAL CONCHA COLUMN; HUMIDIFIER, RESPIRATORY GAS, (
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TELEFLEX MEDICAL HUDSON UNIVERSAL CONCHA COLUMN; HUMIDIFIER, RESPIRATORY GAS, ( Back to Search Results
Catalog Number 382-10
Device Problem False Alarm (1013)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/30/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
The complaint is reported as: "the heater would not stop "low water" alarm with 2/3 full of a water bottle attached.Therapist squeezed the water bottle and alarm condition went away.It started again and i squeezed the water bottle and made sure that i saw the water flow in the bottom water feed line.The alarm came back a third time we squeezed it again but it would not turn off.The therapist changed the column out and handed it to me to drain at the sink and there was no water in it at all." no report of patient injury.Patient current condition is listed as "fine".
 
Manufacturer Narrative
Qn# (b)(4).One (1) 382-10 universal concha column was received for investigation.Upon receipt a visual inspection was performed to determine if the column had been subjected to any misuse/abuse/damage.Nothing was noted.The check valve discs in all three valves were operable as the column valves were turned from one side to the other, showing the discs themselves were free to move.A syringe connected to the upper tube was used to push and pull upper check valves.The column to bottle/bottle to column valves opened and closed freely.As the column was turned upside down the magnetic float was heard sliding up and down the fill sensing tube.The returned column was then connected to a concha water bottle in correct positioning and both upper and lower tubes were punctured into the concha water bottle.The conchasmart column filled to the bottom of level sensing tube and stopped as expected.This test validated the column lower fill valve was working correctly.The water bottle was emptied with only a trace of water at the lower bottle water port.The neptune was setup with an adult breathing circuit, pressure relief valve, 1750 ml water bottle, and a universal temperature probe.The neptune was turned on and the following settings were established on the heater: circuit air temp was set 37 c, rainout was moved as far to the right as possible which represents heavy rainout, and the mode was set to invasive.The neptune settings were accepted.The neptune ran until the water level dropped slightly below the bottom water port.Once the water level reached that point the low water indicator lamp which is located on the front panel of the heater came on.The complaint that the low water indicator lamp on the neptune would not go off while monitoring the water level in the sample column cannot be confirmed.The device history record of the code number ip-5041ns with batch number 74a1901664 reported in the customer complaint has been reviewed and no issues or discrepancies were found which could potentially relate to the reported complaint.No non-conformance reports were originated for the lot in question that can be associated to the complaint reported.The dhr shows that the product was assembled and inspected according to specifications.
 
Event Description
The complaint is reported as: "the heater would not stop "low water" alarm with 2/3 full of a water bottle attached.Therapist squeezed the water bottle and alarm condition went away.It started again and i squeezed the water bottle and made sure that i saw the water flow in the bottom water feed line.The alarm came back a third time we squeezed it again but it would not turn off.The therapist changed the column out and handed it to me to drain at the sink and there was no water in it at all." no report of patient injury.Patient current condition is listed as "fine".
 
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Brand Name
HUDSON UNIVERSAL CONCHA COLUMN
Type of Device
HUMIDIFIER, RESPIRATORY GAS, (
Manufacturer (Section D)
TELEFLEX MEDICAL
research triangle park NC
Manufacturer (Section G)
TELEFLEX MEDICAL
parque industrial finsa
nuevo laredo 88275
MX   88275
Manufacturer Contact
katharine tarpley
3015 carrington mill blvd
morrisville, NC 27560
9194334854
MDR Report Key8728532
MDR Text Key148998211
Report Number3004365956-2019-00164
Device Sequence Number1
Product Code BTT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K141940
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 05/30/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/24/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number382-10
Device Lot Number74A1901664
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/10/2019
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/17/2019
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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