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

Catalog Number 1607

Device Problem Gas/Air Leak (2946)

Patient Problem No Patient Involvement (2645)

Event Date 04/10/2019

Event Type  malfunction  

Manufacturer Narrative

Qn#: (b)(4).One (1) 1607 ventilator tubing set, long length was received for investigation.The ventilator tubing set was visually inspected for any signs of abuse/misuse/damage.Nothing was noted.The dual limb 1607 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 25 ml/min.The 1607 ventilator tubing set does leak, but well within the established iso acceptable parameters.The device history record of batch number 74l1802028 has been 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 specifications.The ifu states for this product states, "ensure all connections are secure, all unused ports are capped, and water traps (if enclosed) are sealed properly".Based on the investigation performed, the reported complaint was confirmed.The complaint sample was tested against iso standard 5367 annex e which states at 60 +/- 3 cmh2o of pressure with incoming equipment pressure set a 30 psi the acceptable leak value is = 30 ml/min.The sample was well within the iso specified leakage value.

Event Description

The complaint is reported as: "product does not pass ventilator pressure test on npb980 vent - only reaches 72, not 75 minimum pressure".No patient involvement.

• Brand Name: HUDSON VENTILATOR TUBING SET,LONG LENGTH
• Type of Device: CIRCUIT, BREATHING (W CONNECTO
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; parque industrial finsa; nuevo laredo 88275 ; MX 88275
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 8590432
• MDR Text Key: 145633252
• Report Number: 3004365956-2019-00104
• Device Sequence Number: 1
• Product Code: CAI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 1607
• Device Lot Number: 74L1802028
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/10/2019
• Initial Date FDA Received: 05/08/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/15/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1