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: TELEFLEX MEDICAL HUDSON HUMIDIFIER,DISPOSABLE; HUMIDIFIER, RESPIRATORY GAS, (
  • 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
 

TELEFLEX MEDICAL HUDSON HUMIDIFIER,DISPOSABLE; HUMIDIFIER, RESPIRATORY GAS, ( Back to Search Results
Model Number IPN913994
Device Problem No Flow (2991)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/25/2021
Event Type  malfunction  
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 was performed and no relevant findings were identified.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 Description
It was reported that: "after a week of use, the o2 flow is no longer delivered.It makes noise.By removing the white filter, the flow returns to normal".No patient injury or harm reported.Patient condition unknown at time of report.Request for additional information has been unsuccessful.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
HUDSON HUMIDIFIER,DISPOSABLE
Type of Device
HUMIDIFIER, RESPIRATORY GAS, (
Manufacturer (Section D)
TELEFLEX MEDICAL
morrisville NC
MDR Report Key12220890
MDR Text Key263398300
Report Number3004365956-2021-00210
Device Sequence Number1
Product Code BTT
UDI-Device Identifier14026704657169
UDI-Public14026704657169
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial
Report Date 07/01/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/23/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model NumberIPN913994
Device Catalogue Number3230
Device Lot Number74G2000926
Was Device Available for Evaluation? No
Date Manufacturer Received07/01/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/06/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
-
-