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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 05/16/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
Customer complaint alleges "unit is not heating up during use on a patient".No patient harm reported.Patient condition reported as "fine".
 
Manufacturer Narrative
Qn#(b)(4).The sample was returned for evaluation.It was found that the thermal-fuse prevented the unit from generating heat.The thermal-fuse was replaced and the unit operated within specifications.The dhr show that the heater was working within specifications at the time of release.The approximate age of the heater is 297 days.Based on the investigation performed, the reported complaint was confirmed.The unit was repaired and returned.
 
Event Description
Customer complaint alleges "unit is not heating up during use on a patient".No patient harm reported.Patient condition 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 Key7596087
MDR Text Key110883323
Report Number3011137372-2018-00155
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 user facility
Type of Report Initial,Followup
Report Date 05/22/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/13/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue Number5705
Device Lot NumberSN:21929
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/31/2018
Date Manufacturer Received07/11/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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