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

Catalog Number 048-91

Device Problem Moisture or Humidity Problem (2986)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/13/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A verification of failure mode reported in the current manufacturing process was conducted as follows: 8 devices were taken from the current production, the samples were functionally inspected, and during the test the issue reported was not observed in the current manufacturing process.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

Customer reported moisture was building up in the device.No patient harm was reported.

Event Description

Customer reported moisture was building up in the device.No patient harm was reported.

Manufacturer Narrative

(b)(4).The sample was performed for evaluation.A visual exam was performed and no issues were encountered.Functional testing was also performed and the unit passed all testing.A device history record review was performed and no relevant findings were identified.Based on the investigation performed, the reported complaint could not be confirmed.There were no issues found with the returned sample.The unit functioned as intended.

• Brand Name: HUDSON AQUATHERM HEATER 091
• Type of Device: HEATER, BREATHING SYSTEM W/WO
• MDR Report Key: 9770821
• MDR Text Key: 181974126
• Report Number: 3003898360-2020-00226
• 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: 02/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 048-91
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2020
• Date Manufacturer Received: 03/26/2020
• 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
• Treatment: NONE REPORTED.; NONE REPORTED.