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

Model Number	IPN049845
Medical Device Problem Code	Insufficient Heating (1287)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/25/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported ""aquatherm unable to perform heat function".No patient involvement reported.
Additional Manufacturer Narrative
(b)(4).The sample was returned for evaluation.A visual exam was performed and no defects were observed.Functional testing was also performed and the unit passed all tests except for the current line and voltage requirements and the leak test.A device history record review was performed and no relevant findings were identified.Based on the investigation performed, the reported complaint was confirmed.During the investigation it was found that the thermal fuse was damaged.The root cause could not be identified as the unit was returned damaged.
Event or Problem Description
It was reported ""aquatherm unable to perform heat function".No patient involvement reported.

• Brand Name: HUDSON AQUATHERM III,ELECTRONIC HEATER
• Common Device Name: HEATER, BREATHING SYSTEM W/WO
• MDR Report Key: 11267896
• Report Number: 3003898360-2021-00070
• Device Sequence Number: 3132169
• Product Code: BZE
• UDI-Device Identifier: 14026704660794
• UDI-Public: 14026704660794
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2021

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
• Operator of Device: No Information
• Device Model Number: IPN049845
• Device Catalogue Number: 050-14
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2021
• Initial Date Received by Manufacturer: 01/16/2021
• Supplement Date Received by Manufacturer: 04/07/2021
• Initial Report FDA Received Date: 02/02/2021
• Supplement Report FDA Received Date: 04/08/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1