MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2019-10-18 for GIRAFFE OMNIBED 6650-0004-901 manufactured by Ge Medical Systems Ultrasound & Primary Care.
| Report Number | 3005860720-2019-00004 |
| MDR Report Key | 9207595 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2019-10-18 |
| Date of Report | 2019-10-18 |
| Date of Event | 2019-09-13 |
| Date Mfgr Received | 2019-09-27 |
| Device Manufacturer Date | 2014-12-16 |
| Date Added to Maude | 2019-10-18 |
| 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 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JOHN SZALINSKI |
| Manufacturer Street | 3000 N GRANDVIEW BLVD. |
| Manufacturer City | WAUKESHA WI |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GIRAFFE OMNIBED |
| Generic Name | INCUBATOR, NEONATAL |
| Product Code | FMZ |
| Date Received | 2019-10-18 |
| Model Number | 6650-0004-901 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GE MEDICAL SYSTEMS ULTRASOUND & PRIMARY CARE |
| Manufacturer Address | 9900 INNOVATION DRIVE WAUWATOSA, WI 53226 US 53226 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2019-10-18 |