MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-05-08 for HUDSON VENTILATOR TUBING SET,LONG LENGTH 1607 manufactured by Teleflex Medical.
[145633252]
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.
Patient Sequence No: 1, Text Type: N, H10
[145633253]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004365956-2019-00104 |
| MDR Report Key | 8590432 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-05-08 |
| Date of Report | 2019-04-10 |
| Date of Event | 2019-04-10 |
| Date Mfgr Received | 2019-04-10 |
| Device Manufacturer Date | 2018-11-15 |
| Date Added to Maude | 2019-05-08 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | KATHARINE TARPLEY |
| Manufacturer Street | 3015 CARRINGTON MILL BLVD |
| Manufacturer City | MORRISVILLE NC 27560 |
| Manufacturer Country | US |
| Manufacturer Postal | 27560 |
| Manufacturer Phone | 9194334854 |
| Manufacturer G1 | TELEFLEX MEDICAL |
| Manufacturer Street | PARQUE INDUSTRIAL FINSA |
| Manufacturer City | NUEVO LAREDO 88275 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 88275 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HUDSON VENTILATOR TUBING SET,LONG LENGTH |
| Generic Name | CIRCUIT, BREATHING (W CONNECTO |
| Product Code | CAI |
| Date Received | 2019-05-08 |
| Returned To Mfg | 2019-04-17 |
| Catalog Number | 1607 |
| Lot Number | 74L1802028 |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | RESEARCH TRIANGLE PARK NC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-08 |