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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 Patient Involvement (2645)
Event Date 02/09/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The device involved in this complaint has been received by the manufacturer.However, the investigation into said device is still in progress at the time of this report.A device history record investigation did not show issues related to this complaint.A record assessment (fmea) was conducted , and no update is required.Verification of failure mode reported in the current manufacturing process was conducted as follows: 13 devices were taken from the current production p/n 048-91 aquatherm heater 091, lot # 73b180002.The samples were functionally inspected, and during the test, the issue reported was not observed in the current manufacturing process.A follow up report will be filed upon completion of the device evaluation.
 
Event Description
Customer complaint alleges "i have an aquatherm heater serial # (b)(4) that is not heating up".Usage of the device is unknown at the time of the alleged malfunction.There was no report of patient involvement.
 
Event Description
Customer complaint alleges "i have an aquatherm heater serial # (b)(4) that is not heating up".Usage of the device is unknown at the time of the alleged malfunction.There was no report of patient involvement.
 
Manufacturer Narrative
Qn# (b)(4).The sample was returned for evaluation.A visual exam was performed and no defects were observed.Functional testing was performed; however, a current test could not be performed due to an open circuit.It is possible that the open circuit was due to overheating of the unit.Based on the investigation performed, the reported complaint was confirmed.All aquatherm heaters are 100% inspected during manufacturing; therefore, a defect of this type would be detected prior to release from the manufacturing facility.It was determined that operational context caused or contributed to the reported defect.
 
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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
MDR Report Key7309232
MDR Text Key101528786
Report Number3003898360-2018-00097
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 02/09/2017
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 Number048-91
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/21/2018
Initial Date Manufacturer Received 02/09/2017
Initial Date FDA Received03/02/2018
Supplement Dates Manufacturer Received03/21/2018
Supplement Dates FDA Received03/23/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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