MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-28 for GAMMA CAMERA manufactured by Siemens Medical Solutions Usa, Inc..
[128572877]
Acquisition computer spontaneously rebooted with 50 seconds remaining on a 90 minute acquisition. Data recovery was attempted with assistance from siemens. Was informed that the data was lost due to the computer rebooting during the acquisition. Certified nuclear medicine technologist (cnmt) was present during the dynamic acquisition. Registered technologist (rt) contacted siemens and the nuclear medicine supervisor to attempt data recovery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8109841 |
| MDR Report Key | 8109841 |
| Date Received | 2018-11-28 |
| Date of Report | 2018-11-21 |
| Date of Event | 2018-05-21 |
| Report Date | 2018-11-21 |
| Date Reported to FDA | 2018-11-21 |
| Date Reported to Mfgr | 2018-11-28 |
| Date Added to Maude | 2018-11-28 |
| 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 |
| Generic Name | GAMMA CAMERA |
| Product Code | IYX |
| Date Received | 2018-11-28 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS MEDICAL SOLUTIONS USA, INC. |
| Manufacturer Address | 810 INNOVATION DRIVE KNOXVILLE TN 37932 US 37932 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-11-28 |