FDA Adverse Event
Other
Summary report: N
VAPOTHERM
MDR report key: 655442
·
Received December 22, 2005
Report
- Report Number
- 655442
- Event Type
- Other
- Date Received
- December 22, 2005
- Date of Event
- December 22, 2005
- Report Date
- December 22, 2005
- Manufacturer
- VAPOTHERM, INC.
- Product Code
- BTT
- Report Source
- User Facility report
- Reporter Location
- SC, US
Narratives
Description of Event or Problem · 1
WE HAVE BEEN USING VAPOTHERM IN OUR NEONATAL INTENSIVE CARE UNIT FOR 1-1 1/2 YEARS. LATE SUMMER WE HEARD OF REPORTS OF POSSIBLE PROBLEMS WITH CONTAMINATION WITH RALSTONIA. WE MONITOR ALL POSITIVE CULTURES AND HAD NOT SEEN RALSTONIA. WE DID SEE AN INCREASE NUMBER OF GRAM NEGATIVE INFECTIONS, WITH MOST BEING ENTEROBACTOR OR BURKHOLDERIA CEPACIA. WE NOTED THAT ALL NEONATES WITH B CEPACIA HAD BEEN ON VAPOTHERM. THERE ARE FIVE INFANTS WHO HAVE BEEN IDENTIFIED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VAPOTHERM | RESPIRATORY GAS ADMINISTRATION DEVICE | BTT | VAPOTHERM, INC. | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |