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 |