MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-07-18 for GIRAFFE ISOLETTE 6650-0001-901 manufactured by Ge Healthcare - Healthcare Services Datex-ohmeda.
[80750869]
Giraffe isolette malfunctioned while in use. Alarmed "system failure 25". Rebooted 3 times, it won't even allow opening the top. Did not cause any harm to the baby. Isolette changed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5071107 |
| MDR Report Key | 6728399 |
| Date Received | 2017-07-18 |
| Date of Report | 2017-07-07 |
| Date of Event | 2017-06-24 |
| Date Added to Maude | 2017-07-20 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 | GIRAFFE ISOLETTE |
| Generic Name | INCUBATOR |
| Product Code | FMZ |
| Date Received | 2017-07-18 |
| Model Number | 6650-0001-901 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GE HEALTHCARE - HEALTHCARE SERVICES DATEX-OHMEDA |
| Manufacturer Address | DALLAS TX US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-07-18 |