MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-26 for GE DIGITAL ENERGY SG SERIES 20 KVA UNK manufactured by Ge Consumer & Industrial Sa.
[131933237]
A ge digital energy sg series 20kva uninterruptible power supply (ups) did not deliver power to an interventional imaging system when the facility lost utility power. The loss of power to the imaging system resulted in a delay and relocation of the pt's procedure.
Patient Sequence No: 0, Text Type: D, B5
| Report Number | 8209627 |
| MDR Report Key | 8209627 |
| Date Received | 2018-12-26 |
| Date of Report | 2018-12-21 |
| Date of Event | 2018-12-11 |
| Date Facility Aware | 2018-12-11 |
| Report Date | 2018-12-21 |
| Date Reported to Mfgr | 2018-12-12 |
| Date Added to Maude | 2019-01-02 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | 0 |
| Brand Name | GE DIGITAL ENERGY |
| Generic Name | SG SERIES 20KVA |
| Product Code | IZO |
| Date Received | 2018-12-26 |
| Model Number | SG SERIES 20 KVA |
| Catalog Number | UNK |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 8 YR |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GE CONSUMER & INDUSTRIAL SA |
| Manufacturer Address | RIAZZINO (LOCARNO) CH-6595 SZ CH-6595 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 0 | 0 | 1. Death | 2018-12-26 |