MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-15 for GIRAFFE OMNIBED GE MEDICAL INCUBATOR/INFANT WARMER 2082844-001-487119 manufactured by Ge Medical Systems Ultrasound And Primary Care Diagnostics.
[175828386]
Neonatal found on the floor next to the ge medical incubator/infant warmer (ein: (b)(4)). The baby was found face down on tummy by nurse who was charting across the way on the computer on wheels. Ng tube still intact, pulse oximetry off, leads off. No critical alarms sounding. Per nurse, it appeared that the baby had fallen out the porthole close to the head of the bed. The manufacturer has not provided the facility with the educational posters as of 01/13/2020.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5092271 |
| MDR Report Key | 9595948 |
| Date Received | 2020-01-15 |
| Date of Report | 2020-01-13 |
| Date of Event | 2020-01-08 |
| Date Added to Maude | 2020-01-16 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| 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 | 3 |
| Brand Name | GIRAFFE OMNIBED GE MEDICAL INCUBATOR/INFANT WARMER |
| Generic Name | INCUBATOR, NEONATAL |
| Product Code | FMZ |
| Date Received | 2020-01-15 |
| Catalog Number | 2082844-001-487119 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GE MEDICAL SYSTEMS ULTRASOUND AND PRIMARY CARE DIAGNOSTICS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other | 2020-01-15 |