MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2011-03-30 for ACUITY H77 manufactured by Varian Medical.
[1950219]
Acuity imaging arms can lead to geometric positioning errors. It is possible that a single failure of a primary encoder can lead to geometric errors that are undetectable. There was no injury to patient or user as a result of this issue, as this issue was discovered during varian's evaluation.
Patient Sequence No: 1, Text Type: D, B5
[9033987]
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 | 8020711-2011-00002 |
| MDR Report Key | 2075135 |
| Report Source | 07 |
| Date Received | 2011-03-30 |
| Date of Report | 2011-03-03 |
| Date of Event | 2011-03-03 |
| Date Mfgr Received | 2011-03-03 |
| Device Manufacturer Date | 2002-09-01 |
| Date Added to Maude | 2012-02-21 |
| 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 M/S C-255 |
| Manufacturer City | PALO ALTO CA 94304 |
| Manufacturer Country | US |
| Manufacturer Postal | 94304 |
| Manufacturer Phone | 6504246471 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACUITY |
| Generic Name | SYSETM, SIMULATION, RADIATION THERAPY |
| Product Code | KPQ |
| Date Received | 2011-03-30 |
| Model Number | H77 |
| ID Number | VERSION 2.2.9.0 |
| Operator | OTHER |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VARIAN MEDICAL |
| Manufacturer Address | PALO ALTO CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-03-30 |