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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HUDSON AQUATHERM HEATER 091; HEATER, BREATHING SYSTEM W/WO
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HUDSON AQUATHERM HEATER 091; HEATER, BREATHING SYSTEM W/WO Back to Search Results
Catalog Number 048-91
Device Problem Insufficient Heating (1287)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/05/2020
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
The complaint is reported as: "the heater lost all heating ability and is not giving a steady temperature." the issue was found during use.The customer has also reported that the "pt was stable and no adverse reactions with the heater not functioning properly." the heater was removed and a removable hme was attached.
 
Manufacturer Narrative
Qn# (b)(4).The unit was returned and sent to the manufacturing site for evaluation.The manufacturing site reports that a visual exam was performed and no defects were observed.It was also reported that functional testing was performed and the unit passed the tests.Based on the investigation performed, the complaint could not be confirmed.There were no issues found with the returned device.
 
Event Description
The complaint is reported as: "the heater lost all heating ability and is not giving a steady temperature." the issue was found during use.The customer has also reported that the "pt was stable and no adverse reactions with the heater not functioning properly." the heater was removed and a removable hme was attached.
 
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Brand Name
HUDSON AQUATHERM HEATER 091
Type of Device
HEATER, BREATHING SYSTEM W/WO
MDR Report Key10417009
MDR Text Key203478713
Report Number3003898360-2020-00669
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,health
Type of Report Initial,Followup
Report Date 08/05/2020
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 Number048-91
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/18/2020
Initial Date Manufacturer Received 08/05/2020
Initial Date FDA Received08/17/2020
Supplement Dates Manufacturer Received09/11/2020
Supplement Dates FDA Received09/14/2020
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 Initial
Patient Sequence Number1
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