MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other,user facility report with the FDA on 2018-04-24 for HUDSON BACTERIAL/VIRAL FILTER 1605 manufactured by Teleflex Medical.
[106388078]
(b)(4). Additional clarification received from the customer reports: the ventilators failed their pre-test flow calibration, but if the filter was changed would pass. The investigation into this complaint is still in progress at the time of this report.
Patient Sequence No: 1, Text Type: N, H10
[106388079]
Customer complaint alleges "ventilators failed initial safety check after changing the bacterial. Event occured 3 times on 3 different ventilators throughout the week. This event never occurred when ventilator is in use on a patient, just when cleaned and being safety tested before storage. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8040412-2018-00115 |
| MDR Report Key | 7455882 |
| Report Source | OTHER,USER FACILITY |
| Date Received | 2018-04-24 |
| Date of Report | 2018-04-11 |
| Date of Event | 2018-03-21 |
| Date Mfgr Received | 2018-06-01 |
| Date Added to Maude | 2018-04-24 |
| 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 |
| 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 | 2018-04-24 |
| Catalog Number | 1605 |
| Lot Number | 201743 |
| Device Availability | N |
| Device Age | DA |
| 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 | 2018-04-24 |