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 Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/12/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the device humidified insufficiently during a pretest before use.Therefore, another unit was used instead.No patient involvement reported.

Event Description

It was reported that the device humidified insufficiently during a pretest before use.Therefore, another unit was used instead.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.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 unit does not exceed the temperature of 25.1 c - trying to reach the maximum value of temperature was not possible.When the unit was opened, it was found that the thermic fusible was damaged.This could result from leaving the unit exposed to a lack of water supplies.The root cause can be attributed to user error, when the unit exceeds 152 c the thermal fuse tends to prevent the unit from continuing to overheat and the fusible opens so that there is no continuity.

• Brand Name: HUDSON AQUATHERM III,JAPANESE
• Type of Device: HEATER, BREATHING SYSTEM W/WO
• MDR Report Key: 10958049
• MDR Text Key: 219866678
• Report Number: 3003898360-2020-00933
• 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: 11/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2020
• 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: 11/17/2020
• Date Manufacturer Received: 02/10/2021
• 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