MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-24 for GE GIRAFFE INCUBATOR CARESTATION 208244-001-487119 manufactured by General Electric Co..
[118463523]
Baby found on floor, side of isolette was down. Nurse found latches were loose when baby placed back in isolette.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5079425 |
| MDR Report Key | 7818957 |
| Date Received | 2018-08-24 |
| Date of Report | 2018-08-22 |
| Date of Event | 2018-08-17 |
| Date Added to Maude | 2018-08-27 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | GE GIRAFFE INCUBATOR CARESTATION |
| Generic Name | INCUBATOR NEONATAL |
| Product Code | FMZ |
| Date Received | 2018-08-24 |
| Model Number | 208244-001-487119 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GENERAL ELECTRIC CO. |
| Manufacturer Address | US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2018-08-24 |