MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2010-03-03 for ACUITY H77-SIM manufactured by Varian Medical Systems.
[1437289]
The customer reported that when a digital shape projector (dsp/field aperture shape is created, the position of the shape displayed on the vision monitor (control console area), is different from the actual dsp shape position displayed on the couch/pt. This shape position error occurs only when the collimator angle is at a value other than 0 degrees. The error is a rotational shift of 90 degrees between the actual shape on the couch and that displayed on the vision monitor. When the collimator is rotated back to zero degrees, the discrepancy disappears. No serious injury to the pt was reported.
Patient Sequence No: 1, Text Type: D, B5
[8485236]
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 | 8020711-2010-00003 |
| MDR Report Key | 1632469 |
| Report Source | 05,06 |
| Date Received | 2010-03-03 |
| Date of Report | 2010-01-13 |
| Date of Event | 2010-01-13 |
| Date Mfgr Received | 2010-02-04 |
| Device Manufacturer Date | 2009-07-01 |
| Date Added to Maude | 2011-03-22 |
| 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 | DAVID HALL, MANAGER |
| Manufacturer Street | 911 HANSEN WAY |
| Manufacturer City | PALO ALTO CA 94304 |
| Manufacturer Country | US |
| Manufacturer Postal | 94304 |
| Manufacturer Phone | 6504833153 |
| Manufacturer G1 | VARIAN MEDICAL SYSTEMS UK LTD. |
| Manufacturer Street | GATWICK RD. |
| Manufacturer City | CRAWLEY, WEST SUSSEX RH109RG |
| Manufacturer Country | UK |
| Manufacturer Postal Code | RH10 9RG |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACUITY |
| Generic Name | SIMULATOR |
| Product Code | KPQ |
| Date Received | 2010-03-03 |
| Model Number | H77-SIM |
| ID Number | V8.9 |
| 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 | 2010-03-03 |