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 2019-09-25 for GIRAFFE OMNIBED manufactured by Ohmeda Medical.
| Report Number | 1121732-2019-00115 |
| MDR Report Key | 9121457 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2019-09-25 |
| Date of Report | 2019-09-25 |
| Date of Event | 2019-09-24 |
| Date Mfgr Received | 2019-09-24 |
| Device Manufacturer Date | 2004-01-02 |
| Date Added to Maude | 2019-09-25 |
| 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 | JOSEPH SELIGA |
| 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 | 2019-09-25 |
| Lot Number | HDGH60869 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OHMEDA MEDICAL |
| Manufacturer Address | 8880 GORMAN RD LAUREL, MD 20723 US 20723 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-09-25 |