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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 1607
Device Problem Gas/Air Leak (2946)
Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
Event Date 11/22/2019
Event Type  malfunction  
Manufacturer Narrative
Qn# (b)(4).
 
Event Description
Customer complaint alleges "unit would not pass the leak test while running an sst on ventilator.Made sure everything was tight and it still did not pass.Tried a new circuit and it passed right away." no report of patient impact or consequence.
 
Manufacturer Narrative
Qn# (b)(4).One complete 1607 ventilator tubing set , long length, was received for investigation.Upon receipt the breathing set was visually inspected or any signs of abuse/misuse/damage.Nothing was noted.The ventilator tubing set was connected to an in-house lab leak tester and 60 +/- 3 cm/h2o of pressure was applied to the circuit.The iso standard states the maximum leak value cannot exceed 70 ml/min.The circuit leaked at rate.07 ml/min which is well below the required 70 ml/min iso standard.This value is also well below the required leakage rate for a neonatal circuit which is 30 ml/min.The device history record of batch number 74f1900167 was reviewed and no issues or discrepancies were found which could potentially relate to this complaint.No non-conformance reports were originated for the lot in question that can be associated to the complaint reported.The dhr shows that the product was assembled and inspected according to specification.Additional testing results reveal the ventilator tubing set leaks well below the assigned leakage rate for a neonatal set.The complaint of leakage has been confirmed, however the leakage rate is well below the assigned leakage rate for this ventilator tube set.
 
Event Description
Customer complaint alleges "unit would not pass the leak test while running an sst on ventilator.Made sure everything was tight and it still did not pass.Tried a new circuit and it passed right away." no report of patient impact or consequence.
 
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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 Key9445161
MDR Text Key191741603
Report Number3004365956-2019-00355
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 user facility
Type of Report Initial,Followup
Report Date 11/22/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/10/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue Number1607
Device Lot Number74F1900167
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/02/2019
Date Manufacturer Received01/03/2020
Patient Sequence Number1
Treatment
NONE REPORTED.; NONE REPORTED.
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