MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2010-12-17 for 4D INTEGRATED TREATMENT CONSOLE H51-TREAT manufactured by Varian Medical Systems.
[1779819]
Therapists reported a "save of session data and/or treatment records failed" warning on the 4ditc on (b)(6) on machine (b)(4). Director of physics located the files from the backup folder and attempted to import them into rtchart. He noted that only 2 of the 3 files imported into rtchart history. He then called the helpdesk for assistance.
Patient Sequence No: 1, Text Type: D, B5
[8847198]
Though still under investigation, varian has determined that a mdr is appropriate, as this malfunction, should it recur, could potentially cause a serious injury. Additional follow-up to this mdr is expected upon completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2916710-2010-00143 |
| MDR Report Key | 1960769 |
| Report Source | 05,06,07 |
| Date Received | 2010-12-17 |
| Date of Report | 2010-12-09 |
| Date of Event | 2010-12-09 |
| Date Mfgr Received | 2010-12-09 |
| Device Manufacturer Date | 2008-01-01 |
| Date Added to Maude | 2012-01-25 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MICHAEL PIGNATARO, MGR. |
| Manufacturer Street | 911 HANSEN WAY |
| Manufacturer City | PALO ALTO CA 94304 |
| Manufacturer Country | US |
| Manufacturer Postal | 94304 |
| Manufacturer Phone | 6504246471 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 4D INTEGRATED TREATMENT CONSOLE |
| Generic Name | LINEAR ACCELERATOR SOFTWARE |
| Product Code | LHN |
| Date Received | 2010-12-17 |
| Model Number | H51-TREAT |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VARIAN MEDICAL SYSTEMS |
| Manufacturer Address | PALO ALTO CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-12-17 |