MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-07 for ACCELERATOR, LINEAR, MEDICAL manufactured by Varian Medical Systems, Inc..
[173913109]
The patient that was on the table received a partial treatment, after 1 hour the machine was back up and the patient completed their treatment. The patient did not want to wait and was cancelled and not treated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9557520 |
| MDR Report Key | 9557520 |
| Date Received | 2020-01-07 |
| Date of Report | 2019-12-17 |
| Date of Event | 2019-09-18 |
| Report Date | 2019-12-17 |
| Date Reported to FDA | 2019-12-17 |
| Date Reported to Mfgr | 2020-01-07 |
| Date Added to Maude | 2020-01-07 |
| 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 | 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 | 3 |
| Generic Name | ACCELERATOR, LINEAR, MEDICAL |
| Product Code | IYE |
| Date Received | 2020-01-07 |
| Lot Number | 83546 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VARIAN MEDICAL SYSTEMS, INC. |
| Manufacturer Address | 911 HANSEN WAY PALO ALTO CA 94304 US 94304 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-07 |