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

Model Number IPN049845

Device Problem Insufficient Heating (1287)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/25/2020

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

It was reported ""aquatherm unable to perform heat function".No patient involvement reported.

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 Description

It was reported ""aquatherm unable to perform heat function".No patient involvement reported.

• Brand Name: HUDSON AQUATHERM III,ELECTRONIC HEATER
• Type of Device: HEATER, BREATHING SYSTEM W/WO
• MDR Report Key: 11267896
• MDR Text Key: 230225124
• Report Number: 3003898360-2021-00070
• Device Sequence Number: 1
• Product Code: BZE
• UDI-Device Identifier: 14026704660794
• UDI-Public: 14026704660794
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: 01/16/2021
• Initial Date FDA Received: 02/02/2021
• Supplement Dates Manufacturer Received: 04/07/2021
• Supplement Dates FDA Received: 04/08/2021
• 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: Reuse
• Patient Sequence Number: 1