MAUDE Adverse Event Report: HUDSON AQUATHERM HEATER 091; HEATER, BREATHING SYSTEM W/WO

Model Number	IPN049841
Medical Device Problem Code	Insufficient Heating (1287)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#: (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 "the heater was plugged in, and would not heat up".No patient involvement reported.
Additional Manufacturer Narrative
Qn#(b)(4).The sample was returned for evaluation.Functional testing was performed and the unit failed the current line and voltage test.It was found that the thermistor was damaged.Because the unit was received damaged, the complaint could not be confirmed and a root cause could not be established.
Event or Problem Description
It was reported "the heater was plugged in, and would not heat up".No patient involvement reported.

• Brand Name: HUDSON AQUATHERM HEATER 091
• Common Device Name: HEATER, BREATHING SYSTEM W/WO
• MDR Report Key: 11870055
• Report Number: 3003898360-2021-00494
• Device Sequence Number: 923674
• Product Code: BZE
• UDI-Device Identifier: 14026704660787
• UDI-Public: 14026704660787
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• 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): 05/04/2021

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: IPN049841
• Device Catalogue Number: 048-91
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2021
• Initial Date Received by Manufacturer: 05/04/2021
• Supplement Date Received by Manufacturer: 06/03/2021
• Initial Report FDA Received Date: 05/24/2021
• Supplement Report FDA Received Date: 06/04/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: N/A.; N/A.