MAUDE Adverse Event Report: HUDSON HUMIDIFIER,DISPOSABLE; HUMIDIFIER, RESPIRATORY GAS, (

Catalog Number 3230

Device Problem No Flow (2991)

Patient Problem No Patient Involvement (2645)

Event Date 09/16/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.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 oxygen does not come out through the port where the hose is connected, it does not have a release valve." the issue was detected prior to use on a patient.

Manufacturer Narrative

Qn# (b)(4).The sample was returned for evaluation.A visual exam was performed and it was observed that there were missing components on the device.Based on the visual exam, the complaint is confirmed.A nonconformance has been opened to address this issue.

Event Description

The complaint is reported as: "the oxygen does not come out through the port where the hose is connected, it does not have a release valve." the issue was detected prior to use on a patient.

• Brand Name: HUDSON HUMIDIFIER,DISPOSABLE
• Type of Device: HUMIDIFIER, RESPIRATORY GAS, (
• MDR Report Key: 10641829
• MDR Text Key: 210202350
• Report Number: 3004365956-2020-00202
• Device Sequence Number: 1
• Product Code: BTT
• 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: 09/17/2020

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: 3230
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2020
• Initial Date Manufacturer Received: 09/17/2020
• Initial Date FDA Received: 10/07/2020
• Supplement Dates Manufacturer Received: 01/06/2021
• Supplement Dates FDA Received: 01/06/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1