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

Catalog Number 050-14

Device Problem Insufficient Heating (1287)

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

Event Date 11/03/2020

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 unit is not heating prior to patient use.No patient involvement reported.

Manufacturer Narrative

Qn#(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 failed two of the tests - the current line and voltage requirements and 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 open and the unit was broken inside.The root cause could not be attributed to manufacturing related.

Event Description

The complaint is reported as: the unit is not heating prior to patient use.No patient involvement reported.

• Brand Name: HUDSON AQUATHERM III,ELECTRONIC HEATER
• Type of Device: HEATER, BREATHING SYSTEM W/WO
• MDR Report Key: 10901164
• MDR Text Key: 218987957
• Report Number: 3003898360-2020-00922
• Device Sequence Number: 1
• Product Code: BZE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 11/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 050-14
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2020
• Date Manufacturer Received: 03/01/2021
• 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