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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HUDSON AQUATHERM III,JAPANESE; HEATER, BREATHING SYSTEM W/WO
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HUDSON AQUATHERM III,JAPANESE; HEATER, BREATHING SYSTEM W/WO Back to Search Results
Catalog Number 050-12J
Device Problem Insufficient Heating (1287)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/13/2021
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed and no relevant findings were identified.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
It was reported "the temperature was below the defined one.(according to the rep, it was 121.7 degree c/max, although our range is from 124 to 127 degree c/max.)".No patient harm or injury reported.Patient condition reported as "fine".
 
Event Description
It was reported "the temperature was below the defined one.(according to the rep, it was 121.7 degree c/max, although our range is from 124 to 127 degree c/max.)".No patient harm or injury reported.Patient condition reported as "fine".
 
Manufacturer Narrative
Qn#(b)(4).The sample was returned for evaluation.A visual exam was performed and it was observed that the device was used by the customer.No defects were detected.Functional testing was also performed and the device passed all tests.There were no heating issues found with the returned device.The unit functioned as intended.The complaint could not be confirmed.
 
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Brand Name
HUDSON AQUATHERM III,JAPANESE
Type of Device
HEATER, BREATHING SYSTEM W/WO
MDR Report Key11752525
MDR Text Key248175928
Report Number3003898360-2021-00435
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,foreig
Type of Report Initial,Followup
Report Date 04/13/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/30/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue Number050-12J
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/17/2021
Date Manufacturer Received09/14/2021
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
Treatment
N/A.
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