MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; NEPTUNE HEATED HUMIDIFIER,CONCHASMART

Catalog Number HUD42500

Device Problem Temperature Problem (3022)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/24/2023

Event Type  malfunction  

Manufacturer Narrative

Per the facility on 09/24/2023 the respiratory therapist "noticed a burn on the heated wire expiratory limb connection/adapter that goes into the heated wire cable".Per the facility the device/tubing was not covered by anything and the temp setting on the device was/is unknown.Per the facility they replaced the circuit, and the patient was not injured.No additional information is available at this time.The sample was requested for evaluation.It has been determined that the reported event could cause or contribute to serious injury if it were to occur.In an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

Event Description

Per the facility on 09/24/2023 the respiratory therapist "noticed a burn on the heated wire expiratory limb connection/adapter that goes into the heated wire cable".

Manufacturer Narrative

Updated.

• Type of Device: NEPTUNE HEATED HUMIDIFIER,CONCHASMART
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: justin herrmann ; three lakes drive; northfield, IL 60093
• MDR Report Key: 18150142
• MDR Text Key: 329602877
• Report Number: 1417592-2023-00454
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/05/2023

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 Catalogue Number: HUD42500
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/27/2023
• Initial Date FDA Received: 11/16/2023
• Supplement Dates Manufacturer Received: 12/01/2023
• Supplement Dates FDA Received: 12/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other