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 2019-03-24 for HUDSON BACTERIAL/VIRAL FILTER 1605 manufactured by Teleflex Medical.
[139701728]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[139701729]
Customer complaint alleges "there must be a leak in the filters because our ventilators would not pass the leak test with the inspiratory filter inline, but would pass without". Alleged issue reported detected during functional testing of the ventilator set up prior to a patient use. No patient injury or complication was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8040412-2019-00087 |
| MDR Report Key | 8446684 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-03-24 |
| Date of Report | 2019-03-19 |
| Date of Event | 2019-03-08 |
| Date Mfgr Received | 2019-05-08 |
| Date Added to Maude | 2019-03-24 |
| 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 | PO BOX 28, KAMUNTING INDUSTRIAL ESTATE |
| Manufacturer City | PERAK, WEST MALAYSIA 34600 |
| Manufacturer Country | MY |
| Manufacturer Postal Code | 34600 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HUDSON BACTERIAL/VIRAL FILTER |
| Generic Name | FILTER, BACTERIAL, BREATHING-C |
| Product Code | CAH |
| Date Received | 2019-03-24 |
| Catalog Number | 1605 |
| Lot Number | 201826 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | PERAK, WEST MALAYSIA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-03-24 |