MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON VENTILATOR TUBING SET,LONG LENGTH; CIRCUIT, BREATHING (W CONNECTO

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.

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).One (1) 1613 ventilator tubing set, long length was returned for investigation.This circuit had already been out of the bag for leak testing at the customer site.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 set, long length was setup for leak test on a lab leak tester.Per iso standard 5367 annex e, the ventilator tubing set was 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 14 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 set does leak, but well within the established iso acceptable parameters.No further action required.

• 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 Key: 8039565
• MDR Text Key: 126388279
• Report Number: 3004365956-2018-00332
• Device Sequence Number: 1
• Product Code: CAI
• Combination Product (y/n): N
• Number of Events Reported: 1
• 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 Received: 11/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 1613
• Device Lot Number: 74G1800986
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2018
• Date Manufacturer Received: 11/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NONE REPORTED.; NONE REPORTED.