MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON RESERVOIR,CONCHA MINI 760 ML; HUMIDIFIER, RESPIRATORY GAS, (

Catalog Number 381-52

Device Problems False Alarm (1013); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/18/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A visual, dimensional, and functional inspection of the device involved in the complaint could not be conducted since the device was not returned at the time of this report.A device history record review could not be not performed since customer did not provide lot number.Complaint not confirmed based on the information received.No sample received from the customer to investigate.Root cause unknown.Teleflex will continue to monitor feedback from the customers on issues related to low water alarm did not reset on water bottle products.If the device sample is received at a later date this report will be updated with the evaluation results.

Event Description

Customer complaint alleges that the "low water alarm was going off.Water bottle was replaced.The alarm never went off.Finally the column was replaced and the low water alarm stopped." alleged event reported as occurred during use.Customer reports no injury or consequence to the patient.Patient condition reported as "fine".

• Brand Name: HUDSON RESERVOIR,CONCHA MINI 760 ML
• Type of Device: HUMIDIFIER, RESPIRATORY GAS, (
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; 900 west university dr.; arlington heights IL 60004
• Manufacturer Contact: linda woodall ; 3015 carrington mill blvd; morrisville 27560 ; 9196942566
• MDR Report Key: 6928920
• MDR Text Key: 89532339
• Report Number: 1417411-2017-00051
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K760866
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/19/2017

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: 381-52
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/19/2017
• Initial Date FDA Received: 10/09/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1