MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-04-01 for * 2000I manufactured by Vapotherm, Inc..
[811045]
Visible residual was seen in the tubing of a vapotherm cpap unit in use on a patient. Tubing cultured and grew out the organism ralstonia pickettii. A second unit grew out the same organism. No growth from any of the clean units.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1022839 |
| MDR Report Key | 1022839 |
| Date Received | 2008-04-01 |
| Date of Report | 2008-04-01 |
| Date of Event | 2008-01-20 |
| Report Date | 2008-04-01 |
| Date Reported to FDA | 2008-04-01 |
| Date Added to Maude | 2008-04-03 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | * |
| Generic Name | HIGH FLOW CANNULA, CPAP |
| Product Code | BTK |
| Date Received | 2008-04-01 |
| Model Number | 2000I |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 989072 |
| Manufacturer | VAPOTHERM, INC. |
| Manufacturer Address | 198 LOG CANOE CIRCLE STEVENSVILLE MD 21666 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-04-01 |