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: HUDSON UNIVERSAL CONCHA COLUMN; 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
 

HUDSON UNIVERSAL CONCHA COLUMN; HUMIDIFIER, RESPIRATORY GAS, ( Back to Search Results
Catalog Number 382-10
Device Problem Improper Flow or Infusion (2954)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/07/2020
Event Type  malfunction  
Manufacturer Narrative
Qn#: (b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.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.If the sample becomes available at a later date a follow up report will be submitted with investigation results.
 
Event Description
The complaint is reported as: "patient on pressure control and prvc not getting volumes." the column was changed and the problem resolved.No patient harm was reported.The patient's condition is reported as fine.
 
Event Description
The complaint is reported as: "patient on pressure control and prvc not getting volumes." the column was changed and the problem resolved.No patient harm was reported.The patient's condition is reported as fine.
 
Manufacturer Narrative
(b)(4).The sample was returned for evaluation.A check valve test was performed and the check valve discs for the conchasmart demonstrated that all three valves would move as the column valves were turned from one side to the other showing the discs themselves were free to move.A syringe connected to the upper tube was used to push and pull upper check valves.Both upper valves moved back and forth freely with no impedance.The returned column was connected to a concha water bottle in correct positioning and both upper and lower tubes were punctured into concha water bottle.The conchasmart column filled to the bottom of the level sensing tube and stopped as expected.This was repeated with a 1/2 full and low (level at bottom of label) water level bottles with the same results.Ventilation testing was also performed.The complaint was unable to be confirmed as the situation was not able to be recreated to show the amount of ventilatory volume difference between clamped and unclamped as documented in the complaint.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
HUDSON UNIVERSAL CONCHA COLUMN
Type of Device
HUMIDIFIER, RESPIRATORY GAS, (
MDR Report Key10567657
MDR Text Key207970988
Report Number3004365956-2020-00186
Device Sequence Number1
Product Code BTT
Combination Product (y/n)N
PMA/PMN Number
K141940
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Type of Report Initial,Followup
Report Date 09/08/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/22/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue Number382-10
Device Lot Number74E2001428
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/14/2020
Date Manufacturer Received11/11/2020
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
NONE REPORTED.; NONE REPORTED.; NONE REPORTED.
-
-