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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HUDSON AQUATHERM III,ELECTRONIC HEATER; HEATER, BREATHING SYSTEM W/WO

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HUDSON AQUATHERM III,ELECTRONIC HEATER; HEATER, BREATHING SYSTEM W/WO Back to Search Results
Catalog Number 050-12R
Device Problem Insufficient Heating (1287)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/03/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.Without the device to evaluate, the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.If the sample becomes available at a later date a follow up report will be submitted with investigation results.
 
Event Description
The complaint is reported as: the unit is not heating prior to patient use.No patient involvement reported.
 
Event Description
The complaint is reported as: the unit is not heating prior to patient use.No patient involvement reported.
 
Manufacturer Narrative
Qn# (b)(4).The sample was returned for evaluation.A visual exam was performed and it was found that the thermal fuse was damaged.No other defects were observed.Functional testing was also performed and the unit passed all tests except for the current line and voltage requirements and leak test.Based on the investigation performed, the reported complaint was confirmed.During the investigation it was found that the thermal fuse was damaged.The unit did not exceed the temperature of 24.9 c - trying to reach the maximum value of temperature was not possible.The root cause could not be identified.
 
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Brand Name
HUDSON AQUATHERM III,ELECTRONIC HEATER
Type of Device
HEATER, BREATHING SYSTEM W/WO
MDR Report Key10901182
MDR Text Key218213718
Report Number3003898360-2020-00926
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 11/06/2020
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 Number050-12R
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/18/2020
Initial Date Manufacturer Received 11/06/2020
Initial Date FDA Received11/25/2020
Supplement Dates Manufacturer Received03/25/2021
Supplement Dates FDA Received03/25/2021
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
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