MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON UNIVERSAL CONCHA COLUMN; HUMIDIFIER, RESPIRATORY GAS, (

Catalog Number 382-10

Device Problem False Alarm (1013)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/20/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device involved in this complaint has not been received for evaluation for the manufacturer at the time of this initial report.However visual and functional inspection was performed to 2 production samples of code ip-5041ns batch 74h1802102 taken randomly from the assembly line.This device uses similar components to catalog number 382-10 reported in this customer complaint.During the inspection no issues or discrepancies were found than can lead to the condition reported by the customer.A device history record review could not be conducted since the lot number provided it is not a valid lot number.Customer complaint cannot be confirmed due the lack of product sample to perform a proper investigation and determine the root cause.If the sample becomes available this report will be updated with the evaluation results.

Event Description

Customer complaint alleges "the low water notification is coming on when the bottle of water is more than full, sometimes 1/2-3/4 full".Event reported during patient use.No patient harm was reported.Patient condition reported as "fine".

Event Description

Customer complaint alleges "the low water notification is coming on when the bottle of water is more than full, sometimes 1/2-3/4 full".Event reported during patient use.No patient harm was reported.Patient condition reported as "fine".

Manufacturer Narrative

(b)(4).One (1) 382-10 universal column was received for investigation.A visual inspection was performed on the column.No visible damage was noted.Functional testing was performed and 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.The column was placed into a 425-00 neptune heater without water.The neptune was turned on and set to 37 degrees "c", with heavy rainout.Within 3 minutes the low water indicator lamp had illuminated.This test confirmed the low water indicator lamp was working as intended.The water bottle was drained until approximately 2 1/2 - 3 inches of water remained.The lower tube of the column was inserted into the lower connection port of the water bottle.The water bottle was suspended onto the neptune.Water flowed into column up to the water level sensing tube as intended.This inspection test confirms the water float in the column is moving up and down accordingly even with lesser volumes of water in the bottle.A device history record review was performed and there were no issues or discrepancies found which could potentially relate to this complaint.No non-conformance reports were originated for the lot in question that can be associated to the complaint reported.The complaint description lends itself to a low water alarm condition only.However, since the low water alarm system is such an integral aspect of the whole neptune/water/column/ operation, the column was subjected to a full array of functional tests, including the low water alarm system.Functional testing did not uncover any operating anomalies with the column to include the low water alarm system.The complaint cannot be confirmed.

• Brand Name: HUDSON UNIVERSAL CONCHA COLUMN
• Type of Device: HUMIDIFIER, RESPIRATORY GAS, (
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• MDR Report Key: 7843723
• MDR Text Key: 119153322
• Report Number: 3004365956-2018-00262
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• PMA/PMN Number: K141940
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/22/2018

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
• Device Operator: No Information
• Device Catalogue Number: 382-10
• Device Lot Number: 74A18
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2018
• Initial Date Manufacturer Received: 08/22/2018
• Initial Date FDA Received: 09/04/2018
• Supplement Dates Manufacturer Received: 10/02/2018
• Supplement Dates FDA Received: 10/02/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NONE REPORTED.; NONE REPORTED.