MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-20 for HUDSON RCI manufactured by Teleflex Medical.
[180171366]
Report of suspicious substances was noted on two (2) separate heat-moisture-exchange (hme) filters on two different units. Upon further visual inspection, the suspicion of mold growth on the hme prompted respiratory to seek a further investigation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9732104 |
| MDR Report Key | 9732104 |
| Date Received | 2020-02-20 |
| Date of Report | 2020-02-11 |
| Date of Event | 2020-01-19 |
| Report Date | 2020-02-11 |
| Date Reported to FDA | 2020-02-11 |
| Date Reported to Mfgr | 2020-02-20 |
| Date Added to Maude | 2020-02-20 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HUDSON RCI |
| Generic Name | HUMIDIFIER NEBULIZER KIT |
| Product Code | OGG |
| Date Received | 2020-02-20 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | 3015 CARRINGTON MILL BLVD MORRISVILLE NC 27560 US 27560 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-20 |