MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-31 for BIOGRAPH VISION 10528958 manufactured by Siemens Medical Solutions Usa, Inc..
[177152466]
Opening shift staff member came in and pet/ct camera was off, she called siemens immediately to try to do several hard shut downs, but gantry still wouldn't come up. She made the lead pet tech aware after she attempted hard shut downs and supervisor aware. Service was called in and arrived around 8:30am and after attempting several shut downs deemed that the power supply was shot and we would be down all day.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9652622 |
| MDR Report Key | 9652622 |
| Date Received | 2020-01-31 |
| Date of Report | 2020-01-15 |
| Date of Event | 2019-12-27 |
| Report Date | 2020-01-15 |
| Date Reported to FDA | 2020-01-15 |
| Date Reported to Mfgr | 2020-01-31 |
| Date Added to Maude | 2020-01-31 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | BIOGRAPH VISION |
| Generic Name | SYSTEM, TOMOGRAPHY, COMPUTED, EMISSION |
| Product Code | KPS |
| Date Received | 2020-01-31 |
| Model Number | 10528958 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS MEDICAL SOLUTIONS USA, INC. |
| Manufacturer Address | 2501 NORTH BARRINGTON RD. HOFFMAN ESTATES IL 60192 US 60192 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-31 |