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

Catalog Number HUD42500

Device Problem Temperature Problem (3022)

Patient Problem Insufficient Information (4580)

Event Date 10/05/2023

Event Type  malfunction  

Event Description

"got hot and burned the circuit".

Manufacturer Narrative

No additional information was provided by the customer.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.

• Type of Device: NEPTUNE HEATED HUMIDIFIER,CONCHASMART
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: kelly zampella ; three lakes drive; northfield, IL 60093
• MDR Report Key: 18059264
• MDR Text Key: 327210442
• Report Number: 1417592-2023-00435
• 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
• Report Date: 11/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: HUD42500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2023
• Initial Date Manufacturer Received: 10/05/2023
• Initial Date FDA Received: 11/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other