MAUDE Adverse Event Report: HUDSON AQUATHERM III,ELECTRONIC HEATER; HUMIDIFIER, RESPIRATORY GAS, (

Model Number	IPN049845
Medical Device Problem Code	Insufficient Heating (1287)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#: (b)(4).
Event or Problem Description
It was reported "the unit is not heating up".No patient involvement reported.
Event or Problem Description
It was reported "the unit is not heating up".No patient involvement reported.
Additional Manufacturer Narrative
(b)(4).The sample was returned and sent to the manufacturing site for evaluation.The manufacturing site reports "by visual inspection the unit presented the thread broken the potentiometer nut does not turn together with the knob." it was also reported that functional testing and the sample failed the leak test.A device history record review was performed and no relevant findings were identified.The complaint has been confirmed; however, a root cause for the issue could not be identified.

• Brand Name: HUDSON AQUATHERM III,ELECTRONIC HEATER
• Common Device Name: HUMIDIFIER, RESPIRATORY GAS, (
• MDR Report Key: 12135145
• Report Number: 3003898360-2021-00586
• Device Sequence Number: 14485940
• Product Code: BTT
• UDI-Device Identifier: 14026704660794
• UDI-Public: 14026704660794
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K131912
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2021

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
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2021
• Initial Date Received by Manufacturer: 06/15/2021
• Supplement Date Received by Manufacturer: 07/20/2021
• Initial Report FDA Received Date: 07/08/2021
• Supplement Report FDA Received Date: 07/21/2021
• 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