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

Catalog Number HUD42500

Device Problem Break (1069)

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Date 02/19/2022

Event Type  Injury  

Manufacturer Narrative

Customer medsun report# (b)(4).It was reported that, while doing rounds, the staff noticed that the heated wire tubing was pulling off of the adaptor that was connected to the concha, exposing the heated wires.The patient experienced a burn injury from the overheated vent tubing.During the nurses routine position change the nurse noted that hot tubing melted to the bedsheet and the patient's hospital gown.A red burn was noted on the patient's abdomen.The patient experienced blistering, a second degree burn and obtained a burn consult.Daily dressing changes were performed.The unit was pulled from service and a new device was available to replace the device and continue with treatment without further incident.The device was returned to the manufacturer for evaluation.After visual inspection there was a crack noted to the right side of the rear mounting bracket and one of the fins was cracked on the left side reservoir mounting bracket.Functional testing was performed and showed that the device operated per specifications.At this time a definitive root cause could not be determined.No additional information is available.Due to the reported incident and 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

It was reported that the heated wires were exposed from the device and the patient sustained a second degree burn to their abdomen.

• Brand Name: NEPTUNE HEATED HUMIDIFIER,CONCHASMART
• Type of Device: NEPTUNE HEATED HUMIDIFIER,CONCHASMART
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: karen trutsch ; three lakes drive; northfield, IL 60093
• MDR Report Key: 13929180
• MDR Text Key: 293540456
• Report Number: 1417592-2022-00047
• 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: 03/28/2022

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: HUD42500
• Device Lot Number: 618080258
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2022
• Initial Date Manufacturer Received: 02/28/2022
• Initial Date FDA Received: 03/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 85 YR
• Patient Sex: Male
• Patient Weight: 75 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White