MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2008-08-11 for ACUITY H77-SIM manufactured by Varian Medical Systems.
[893524]
A varian customer reports the acuity imager / cassette cover detached from the imager and fell to the floor during gantry rotation. In this one instance, a pt was struck in the forehead by the imager / cassette cover, resulting in a bruise, but sustained no other injuries.
Patient Sequence No: 1, Text Type: D, B5
[8113021]
The investigation found that the operator / technician had not properly secured the locking device as shown on the label. The cover would be adequately secured if the velcro were securely pressed on both sides as per the unit's labeling. Varian reviewed all aspects of this complaint and determined that the available labeling, both in the instructions for use and physically applied to the cover, is adequate and complete for the proper installation of this cover. If the locking device (dual-lock) is properly utilized, there is very little chance of the cover detaching from the simulator. The conclusion of this prod eval was that the degree of health hazard presented by the prod is a situation in which use of the device is not likely to cause adverse health consequences. It was therefore appropriate to provide a safe use communication to the installed base, reiterating the instructions for use. The safe use communication was released on 08/07/2007 to thirty-nine sites. Furthermore, varian is reporting the complaint as an mdr in accordance to the direction of the state. No follow-up reports are anticipated.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8020711-2008-00008 |
| MDR Report Key | 1106631 |
| Report Source | 01,05,06 |
| Date Received | 2008-08-11 |
| Date of Report | 2006-11-29 |
| Date of Event | 2006-11-29 |
| Date Mfgr Received | 2008-07-01 |
| Device Manufacturer Date | 2004-09-01 |
| Date Added to Maude | 2008-08-19 |
| 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 | DAVE HALL, MGR |
| 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 City | CRAWLEY 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 | 2008-08-11 |
| Model Number | H77-SIM |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1105817 |
| Manufacturer | VARIAN MEDICAL SYSTEMS |
| Manufacturer Address | PALO ALTO CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2008-08-11 |