Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; NEPTUNE HEATED HUMIDIFIER,CONCHASMART
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MEDLINE INDUSTRIES LP; NEPTUNE HEATED HUMIDIFIER,CONCHASMART Back to Search Results
Catalog Number HUD42500
Device Problem Melted (1385)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/28/2022
Event Type  malfunction  
Event Description
It was reported by the facility representative that the conchacolumn melted to the interior of the heater which is part of the humidifier.
 
Manufacturer Narrative
It was reported by the facility representative that the conchacolumn melted to the interior of the heater which is part of the humidifier.According to the representative the unit was replaced and there was not an impact to the patient or the procedure.The sample was returned for evaluation.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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key13623548
MDR Text Key289070104
Report Number1417592-2022-00021
Device Sequence Number1
Product Code BTT
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other
Type of Report Initial
Report Date 02/28/2022
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 NumberHUD42500
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/21/2022
Initial Date Manufacturer Received 01/31/2022
Initial Date FDA Received02/28/2022
Was Device Evaluated by Manufacturer? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
-
-