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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON THERMAGARD NEBULIZER HEATER; BREATHING SYSTEM HEATER
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TELEFLEX MEDICAL HUDSON THERMAGARD NEBULIZER HEATER; BREATHING SYSTEM HEATER Back to Search Results
Catalog Number 5705
Device Problems Overheating of Device (1437); Temperature Problem (3022)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/14/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The device involved in this complaint has not been received by the manufacturer at the time of this report.The investigation into this complaint is still in progress.
 
Event Description
Customer complaint alleges the device "got so hot you could barely touch it." alleged malfunction reported as detected during functional testing prior to patient use.No report of patient harm.No report of user harm.
 
Manufacturer Narrative
(b)(4).The device was received and sent to the manufacturer for evaluation.The manufacturer reports that: upon receipt of unit, the claim was not confirmed.The power switch did illuminate when turned on, and the unit generated heat.The heater was submitted to electrical safety tests, and a dry performance test for 2 hours, at maximum control knob setting.The heater was found to perform within specifications.The results of the performance output temperature test were within specifications.The instructions for use (ifu) for the unit repeatedly warns of the "burn hazard" risk while handling the device during set-up, water refill, disassemble of system, and cleaning.As a result of our testing, we were not able to duplicate the claim.
 
Event Description
Customer complaint alleges the device "got so hot you could barely touch it." alleged malfunction reported as detected during functional testing prior to patient use.No report of patient harm.No report of user harm.
 
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Brand Name
HUDSON THERMAGARD NEBULIZER HEATER
Type of Device
BREATHING SYSTEM HEATER
Manufacturer (Section D)
TELEFLEX MEDICAL
research triangle park NC
Manufacturer (Section G)
TELEFLEX MEDICAL
3015 carrington mill blvd
morrisville NC 27560
Manufacturer Contact
katharine tarpley
3015 carrington mill blvd
morrisville, NC 27560
9194334854
MDR Report Key6833694
MDR Text Key84092159
Report Number3011137372-2017-00271
Device Sequence Number1
Product Code BZE
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 08/15/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/31/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue Number5705
Device Lot Number21720
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/01/2017
Is the Reporter a Health Professional? No
Date Manufacturer Received09/19/2017
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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