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: COMFORT FLO HUMIDIFICATION SYSTEM; HUMIDIFIER NEBULIZER KIT
  • 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
 

COMFORT FLO HUMIDIFICATION SYSTEM; HUMIDIFIER NEBULIZER KIT Back to Search Results
Model Number IPN913728
Medical Device Problem Code Overfill (2404)
Health Effect - Clinical Code Low Oxygen Saturation (2477)
Date of Event 02/07/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.A device history record review could not be conducted since the lot number of the device was not provided.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.
 
Event or Problem Description
It was reported "the heating column on circuit 2410 "bubbled over" and flooded the circuit, and ended up sending hot water to the patients nose.The patients o2 saturation level dropped, and a new circuit was put on, and they improved right after".Patient condition reported as "fine".
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
COMFORT FLO HUMIDIFICATION SYSTEM
Common Device Name
HUMIDIFIER NEBULIZER KIT
MDR Report Key11400416
Report Number3004365956-2021-00057
Device Sequence Number4760340
Product Code OGG
UDI-Device Identifier14026704659347
UDI-Public14026704659347
Combination Product (Y/N)N
Initial Reporter StatePA
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,user f
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 02/08/2021
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
Operator of Device No Information
Device Model NumberIPN913728
Device Catalogue Number2410
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/08/2021
Initial Report FDA Received Date03/02/2021
Was Device Evaluated by Manufacturer? (Y/N) Device Not Returned to Manufacturer
Is the Device Labeled for Single Use? (Y/N) Yes
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Usage of Device Initial
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
-
-