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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON AQUATHERM HEATER 091; HEATER, BREATHING SYSTEM W/WO
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TELEFLEX MEDICAL HUDSON AQUATHERM HEATER 091; HEATER, BREATHING SYSTEM W/WO Back to Search Results
Catalog Number 048-91
Device Problems Insufficient Heating (1287); Temperature Problem (3022)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/11/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
Customer complaint alleges the device does not heat the water.Alleged issue reported as occurred during use.Reporter states "patient was using this with an air compressor into her trach".There was no report of patient impact or consequence.
 
Manufacturer Narrative
(b)(4).The sample was returned for evaluation.A visual exam was performed and no issues were found.Functional testing was also performed and the unit passed all testing.Acceptable data ranges for the average temperature of the unit is 204 to 218f.The result of the testing of the unit was 212f, which is within specification.Based on the investigation performed, the reported complaint could not be confirmed.There were no issues found with the returned device.
 
Event Description
Customer complaint alleges the device does not heat the water.Alleged issue reported as occurred during use.Reporter states "patient was using this with an air compressor into her trach".There was no report of patient impact or consequence.
 
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Brand Name
HUDSON AQUATHERM HEATER 091
Type of Device
HEATER, BREATHING SYSTEM W/WO
Manufacturer (Section D)
TELEFLEX MEDICAL
research triangle park NC
Manufacturer (Section G)
TELEFLEX MEDICAL
rancho el descanso
tecate 21478
MX   21478
Manufacturer Contact
katharine tarpley
3015 carrington mill blvd
morrisville, NC 27560
9194334854
MDR Report Key7630518
MDR Text Key112282673
Report Number3003898360-2018-00500
Device Sequence Number1
Product Code BZE
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 06/11/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/22/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Catalogue Number048-91
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/19/2018
Is the Reporter a Health Professional? No
Date Manufacturer Received08/08/2018
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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