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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 Problem Gas/Air Leak (2946)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/11/2008
Event Type  malfunction  
Manufacturer Narrative
Qn# (b)(4).
 
Event Description
Customer complaint alleges "the tubing has an air leak which is not good when our patients are on the vent".Usage of the device, at the time the alleged defect was detected, is unknown.No patient harm reported.
 
Manufacturer Narrative
Qn# (b)(4).The actual sample was not returned; however, the customer returned five representative samples of 1613 ventilator tubing sets, long length.A visual inspection was performed to examine the sample for any signs of abuse/misuse/damage.None were noted.The dual limb 1613 ventilator tubing sets, long length was setup for leak test on a lab leak tester.Per iso standard 5367 annex e, the ventilator tubing sets were tested at 60 +/- 3 cmh2o of pressure with incoming equipment pressure set a 30 psi.The acceptable leak value is = 30 ml/min.The actual ml/min pressure recorded at test was 19, 22, 23 , 20, and 21 ml/min.The device history record of batch number 74g1800986 that belongs to catalog number 1613 has been reviewed and no issues or discrepancies were found which could potentially be related 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 specifications.Based on the investigation performed, the reported complaint was confirmed.The 1613 ventilator tubing sets do leak, but well within the established iso acceptable parameters.No further action required.
 
Event Description
Customer complaint alleges "the tubing has an air leak which is not good when our patients are on the vent." usage of the device, at the time the alleged defect was detected, is unknown.No patient harm 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
research triangle park NC
MDR Report Key8039568
MDR Text Key126388295
Report Number3004365956-2018-00334
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 distributor,user facility
Type of Report Initial,Followup
Report Date 10/11/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/05/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue Number1613
Device Lot Number74G1800986
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/14/2018
Date Manufacturer Received11/28/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
NONE REPORTED.; NONE REPORTED.
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