MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2020-02-07 for HUDSON HUMID-FLO HME 19912 manufactured by Teleflex Medical Sdn. Bhd..
[183755296]
Concomitant medical product: (ambu). (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[183755297]
Customer reported a substance was found on the device during use and tested positive for growth of aspergillosis. The customer reported the source of the growth had not been determined at the time of this report and that the ventilator has also been cultured. The patient was not cultured for aspergillosis and did not require any medical intervention or treatment. The patient was reported to be off of the ventilator.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8040412-2020-00039 |
| MDR Report Key | 9682794 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2020-02-07 |
| Date of Report | 2020-01-21 |
| Date of Event | 2020-01-21 |
| Date Mfgr Received | 2020-03-11 |
| Date Added to Maude | 2020-02-07 |
| 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 SDN. BHD. |
| Manufacturer Street | LOT NO : PT2577 JALEN PERUSAHAAN 4 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 HUMID-FLO HME |
| Generic Name | CONDENSER, HEAT AND MOISTURE ( |
| Product Code | BYD |
| Date Received | 2020-02-07 |
| Catalog Number | 19912 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL SDN. BHD. |
| Manufacturer Address | PERAK, WEST MALAYSIA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-07 |