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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HUDSON THERMAGARD NEBULIZER HEATER; BREATHING SYSTEM HEATER
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HUDSON THERMAGARD NEBULIZER HEATER; BREATHING SYSTEM HEATER Back to Search Results
Catalog Number 5705
Device Problem Insufficient Heating (1287)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/03/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
Customer reported the device was not heating up during use.No patient harm reported.
 
Event Description
Customer reported the device was not heating up during use.No patient harm reported.
 
Manufacturer Narrative
Qn#(b)(4).The unit was returned and sent to the manufacturer (pegasus research corp) for evaluation.Pegasus reports that upon initial testing of the unit the claim was confirmed.The power switch did illuminate and the unit did not generate heat.Evaluation revealed a random thermal-fuse failure that prevented the unit from generating heat.The device history record review shows that the heater was working within specifications at the time of release.The approximate age of the unit is (b)(4) days.Based on the investigation performed, the reported complaint was confirmed.The unit will be repaired and returned.
 
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Brand Name
HUDSON THERMAGARD NEBULIZER HEATER
Type of Device
BREATHING SYSTEM HEATER
MDR Report Key9774149
MDR Text Key191038837
Report Number3011137372-2020-00064
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,distri
Type of Report Initial,Followup
Report Date 02/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/02/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue Number5705
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/18/2020
Date Manufacturer Received03/06/2020
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 Reuse
Patient Sequence Number1
Treatment
NONE REPORTED.; NONE REPORTED.
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