MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-06-06 for GIRAFFE SHUTTLE manufactured by Ohmeda Medical.
[76746615]
Patient Sequence No: 1, Text Type: N, H10
[76746616]
Unit was fully charged, but the battery drained 3 minutes into use while transporting a patient. The device was sequestered and tested by both biomed and ge (oem), and the errors and problems could not be duplicated. Ge stated that the unit was functioning as designed, and it was placed back in service. No issues were found with the unit.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6614245 |
| MDR Report Key | 6614245 |
| Date Received | 2017-06-06 |
| Date of Report | 2017-05-17 |
| Date of Event | 2017-01-18 |
| Report Date | 2017-03-14 |
| Date Reported to FDA | 2017-03-14 |
| Date Reported to Mfgr | 2017-03-14 |
| Date Added to Maude | 2017-06-06 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | 3 |
| Brand Name | GIRAFFE SHUTTLE |
| Generic Name | INCUBATOR, NEONATAL |
| Product Code | FMZ |
| Date Received | 2017-06-06 |
| Model Number | GIRAFFE SHUTTLE |
| Device Availability | * |
| Device Age | 1 YR |
| Device Eval'ed by Mfgr | * |
| 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 | 2017-06-06 |