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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 Problem Insufficient Heating (1287)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/14/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
Customer complaint alleges the device is not heating up.No report of patient impact or consequence.Device was replaced with another one.
 
Manufacturer Narrative
(b)(4).The unit was returned and sent to the manufacturer (pegasus research corp) for evaluation.Pegasus reports that "upon receipt of unit the claim was confirmed.Evaluation revealed that the thermal-fuse was opened and prevented the unit from heating.The thermal-fuse was replaced and the unit operated within specifications.Dhr show that the heater was working within specifications at the time of release.The approximate age of the heater is 218 days." based on the investigation performed, the reported complaint was confirmed.The unit was repaired and returned.
 
Event Description
Customer complaint alleges the device is not heating up.No report of patient impact or consequence.Device was replaced with another one.
 
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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 Key8134515
MDR Text Key129379396
Report Number3011137372-2018-00316
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 company representative,user f
Type of Report Initial,Followup
Report Date 11/19/2018
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 Number5705
Device Lot NumberSN:22488
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/05/2018
Initial Date Manufacturer Received Not provided
Initial Date FDA Received12/05/2018
Supplement Dates Manufacturer Received01/10/2019
Supplement Dates FDA Received01/10/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
NONE REPORTED.; NONE REPORTED.; NONE REPORTED.
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