MAUDE MDR 9207595
- MDR report key
- 9207595
- Report number
- 3005860720-2019-00004
- Event key
- 0
- Event type
- 3
- Date of event
- 2019-09-13
- Date received
- 2019-10-18
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 401
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- JOHN SZALINSKI
- Address
- 3000 N GRANDVIEW BLVD. WAUKESHA WI US
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | GIRAFFE OMNIBED | INCUBATOR, NEONATAL | GE MEDICAL SYSTEMS ULTRASOUND & PRIMARY CARE | FMZ | 6650-0004-901 | * | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2019-10-18 | 0 | 1. D |
Event Narratives#
No narrative records found.