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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON VENTILATOR TUBING SET,LONG LENGTH; CIRCUIT, BREATHING (W CONNECTO
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TELEFLEX MEDICAL HUDSON VENTILATOR TUBING SET,LONG LENGTH; CIRCUIT, BREATHING (W CONNECTO Back to Search Results
Catalog Number 1613
Device Problems Loose or Intermittent Connection (1371); Gas/Air Leak (2946)
Patient Problem No Patient Involvement (2645)
Event Date 07/17/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
Customer complaint reported as: we have noticed that several of our ventilator circuits from the same case are not passing the vent pre use check.The circuits feel different than they did previously and one of the pop off valves is quite loose, i am concerned it could directly impact volume we're delivering to patients on mechanical ventilation, thus having severe implications and the potential for a significant adverse event.No patient involvement reported.
 
Manufacturer Narrative
(b)(4).The customer returned one 1613 ventilator tubing set for investigation.Upon receiving the circuit, it was visually examined for any signs of misuse/abuse/damage.No cracks or holes were found.No other obvious defects or anomalies were noted.All port caps were secure and nothing unusual was noted on how the circuit felt.The leak rate specification is governed by iso 5367:2014, annex e, which specifies adult circuit under 60 +- 3 cmh2o of air pressure, cannot exceed a leak rate greater than 70 ml/min.The circuit was hooked up to a leak tester and was leak tested under 60 +/- 3 cmh2o of air pressure.The tubing leaked at a rate of 11 ml/min, which is well below the acceptable iso limit of 70 ml/min.A device history record review was performed and no relevant findings were identified.The reported complaint of a leaking circuit was confirmed based upon the sample received.The returned circuit was confirmed to leak at 11 ml/min.This is well below the iso standard of 70 ml/min.Functional testing did not reveal any operational anomalies.
 
Event Description
Customer complaint reported as: we have noticed that several of our ventilator circuits from the same case are not passing the vent pre use check.The circuits feel different than they did previously and one of the pop off valves is quite loose, i am concerned it could directly impact volume we're delivering to patients on mechanical ventilation, thus having severe implications and the potential for a significant adverse event.No patient involvement reported.
 
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Brand Name
HUDSON VENTILATOR TUBING SET,LONG LENGTH
Type of Device
CIRCUIT, BREATHING (W CONNECTO
Manufacturer (Section D)
TELEFLEX MEDICAL
morrisville NC
MDR Report Key10356517
MDR Text Key201573489
Report Number3004365956-2020-00147
Device Sequence Number1
Product Code CAI
Combination Product (y/n)N
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 07/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/03/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue Number1613
Device Lot Number74E2000290
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/27/2020
Date Manufacturer Received08/31/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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