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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 Insufficient Heating (1287); Temperature Problem (3022)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/15/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The device involved in this complaint has been returned to the manufacturer, however, the investigation of said device is still in progress at the time of this report.A follow up report will be submitted at the conclusion of the investigation.
 
Event Description
Customer complaint alleges the device failed to heat after being turned on for 20 minutes.Event reported as occurred during use for continuous nebulization.There was no report of patient injury or consequence.The patient condition was reported as "fine".
 
Manufacturer Narrative
Qn#(b)(4).The sample was returned for evaluation.The power switch did illuminate when turned on, but did not generate heat.Evaluation revealed that the heater's thermal-fuse was at fault.The component was inspected and did not present any visible defect, and dhr shows that the heater was operable and within specifications at the time of release.This is a random component failure, which is not often seen in this units, especially at this age (294 days approximately).The power switch was replaced and the heater was retested as per procedure and found to meet specifications.
 
Event Description
Customer complaint alleges the device failed to heat after being turned on for 20 minutes.Event reported as occurred during use for continuous nebulization.There was no report of patient injury or consequence.The patient condition was reported as "fine".
 
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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
MDR Report Key7436451
MDR Text Key105719753
Report Number3011137372-2018-00102
Device Sequence Number1
Product Code BZE
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,health pr
Type of Report Initial,Followup
Report Date 03/27/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/17/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue Number5705
Device Lot Number2017H17BY
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/06/2018
Date Manufacturer Received04/26/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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