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 Consequences Or Impact To Patient (2199)

Event Date 07/06/2020

Event Type  malfunction  

Manufacturer Narrative

Qn# (b)(4).

Event Description

Customer reported the unit was not heating up.It was reported the unit was being set up for patient use and the heater was switched out with another one.There was no patient harm.

Manufacturer Narrative

Qn#(b)(4).The sample was returned for evaluation.A visual exam was performed and it was observed that the internal parts contained corrosion and humidity.Functional testing was also performed and the unit passed the tests.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 inspection performed it was found that the unit contained corrosion and humidity , indicating the unit was exposed to water.It was also found that the thermofuse was open.The root cause can be attributed to the user.When the unit is exposed to water, the components tends to generate corrosion that affects the electrical functions that is performed by the thermofuse.

Event Description

Customer reported the unit was not heating up.It was reported the unit was being set up for patient use and the heater was switched out with another one.There was no patient harm.

• Brand Name: HUDSON AQUATHERM III,ELECTRONIC HEATER
• Type of Device: HEATER, BREATHING SYSTEM W/WO
• MDR Report Key: 10336317
• MDR Text Key: 200769744
• Report Number: 3003898360-2020-00562
• 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: 07/08/2020

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 Catalogue Number: 050-14
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2020
• Initial Date Manufacturer Received: 07/08/2020
• Initial Date FDA Received: 07/28/2020
• Supplement Dates Manufacturer Received: 08/14/2020
• Supplement Dates FDA Received: 08/17/2020
• 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
• Treatment: NONE REPORTED.; NONE REPORTED.; NONE REPORTED.