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
Catalog Number 3230
Device Problem Disconnection (1171)
Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
Event Date 01/21/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4) the device involved has not been received by the manufacturer for evaluation at the time of this report.The device history record of batch number 74c1800311 that belongs to catalog number 3230 has been reviewed and no issues or discrepancies were found which could potentially be related to this complaint.Customer complaint cannot be confirmed based only on the information provided, to perform an investigation and determine the source of defect reported it is necessary to evaluate the sample involved on this complaint.However material from the production line was verified and no issues were found that can lead this customer complaint.If the sample becomes available this investigation will be updated with the evaluation results.
 
Event Description
Customer complaint alleges when connecting the device to the oxygen source, the green connector disconnected and the bottle fell to the floor.Event reported as occurred prior to use on a patient during inspection/functional testing.Customer reports there was no patient involvement.
 
Manufacturer Narrative
(b)(4).The sample was returned for evaluation.During the visual exam it was observed that the green connection (p/n: 30147 nut, oxygen) is well assembled to the bottle, not disconnected as it is described in the customer complaint.It was also observed that there was damage on the green connection.Although the received sample was found with damage on the green connection there is not sufficient evidence to assure this damage was originated during the manufacturing process.The root cause for the condition reported could not be identified.Teleflex will continue to monitor and trend complaints of this nature.
 
Event Description
Customer complaint alleges when connecting the device to the oxygen source, the green connector disconnected and the bottle fell to the floor.Event reported as occurred prior to use on a patient during inspection/functional testing.Customer reports there was no patient involvement.
 
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
research triangle park NC
MDR Report Key8377696
MDR Text Key137403694
Report Number3004365956-2019-00052
Device Sequence Number1
Product Code BTT
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,user faci
Type of Report Initial,Followup
Report Date 02/05/2019
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 Operator No Information
Device Catalogue Number3230
Device Lot Number74C1800311
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/11/2019
Initial Date Manufacturer Received 02/05/2019
Initial Date FDA Received02/28/2019
Supplement Dates Manufacturer Received03/27/2019
Supplement Dates FDA Received03/27/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
NONE REPORTED.; NONE REPORTED.; NONE REPORTED.
-
-