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

Catalog Number 050-12J

Device Problem Insufficient Heating (1287)

Patient Problem No Patient Involvement (2645)

Event Date 09/08/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A verification of the reported failure mode was conducted and 8 devices were taken from current production (050-12j aquatherm iii , (b)(6) lot # (b)(4) at the manufacturing facility and were functionally inspected.No issues were encountered during the functional testing.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 temperature of the heater did not increase during the test before use.Therefore, another unit was used instead." no patient involvement.

Event Description

The complaint is reported as: "the temparature of the heater did not increase during the test before use.Therefore, another unit was used instead." no patient involvement.

Manufacturer Narrative

Qn#(b)(4).The sample was returned for evaluation.Functional testing was performed and the unit passed all tests.Dry temperature measurement without opening the unit was performed.When the knob was positioned at the minimum value the unit reached 25.9 c.At the medium value the unit reached 84.5 c and at maximum value the unit reached 120 c.Specification indicates that the maximum temperature should be 124 c.Based on the investigation performed, the complaint was confirmed.It was discovered that the unit was not heating properly.A non-conformance was opened to address this issue.

• Brand Name: HUDSON AQUATHERM III,JAPANESE
• Type of Device: HEATER, BREATHING SYSTEM W/WO
• MDR Report Key: 10566636
• MDR Text Key: 207938584
• Report Number: 3003898360-2020-00757
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 09/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 050-12J
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2020
• Date Manufacturer Received: 11/02/2020
• 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: Unknown
• Patient Sequence Number: 1