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

Catalog Number 381-52

Device Problem Device Sensing Problem (2917)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/17/2018

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.No device history record review was performed since customer did not provide lot number.Complaint not confirmed.Root cause unknown.Teleflex will continue to monitor feedback from the customers on issues related to low water alarm during use on water bottle products.

Event Description

Customer complaint alleges "the water out alarm on the heater goes off when there is still 1/2 to 3/4 water left in the bottle.The clinician will squeeze the bottle to get the magnet off the bottom of the column, and the alarm will return several minutes later." alleged issue reported as occurred during use.It was reported there was no patient injury or consequence.

• 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: 7464635
• MDR Text Key: 106726940
• Report Number: 1417411-2018-00030
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/19/2018

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: 381-52
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/19/2018
• Initial Date FDA Received: 04/26/2018
• 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