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 2010-01-14 for ON-BOARD IMAGER (OBI) H08 manufactured by Varian Medical Systems.
[1315861]
It was reported that during a scheduled oncology treatment, the cover of the obi detector fell off the machine during gantry rotation. Although, the cover detached during treatment and struck the pt in the head, no injury occurred.
Patient Sequence No: 1, Text Type: D, B5
[8346427]
In multiple reports of this malfunction, no serious injury has resulted, and no medical intervention beyond exam and/or diagnostic testing has resulted. Varian service is on schedule to perform a site visit to apply a modification to the device. This modification is a varian approved modification which replaces the originally designed velcro fasteners with retaining screws. Varian has come to a decision to report incidents involving medical intervention (x-ray and ct scans) or observations. In a previous report of this malfunction, a pt was referred for ct exam (which was negative). No additional f/u to this mdr is expected.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2916710-2009-00079 |
| MDR Report Key | 1586895 |
| Report Source | 01,05,06 |
| Date Received | 2010-01-14 |
| Date of Report | 2009-12-22 |
| Date of Event | 2009-12-22 |
| Date Mfgr Received | 2009-12-22 |
| Device Manufacturer Date | 2006-06-01 |
| Date Added to Maude | 2010-02-04 |
| 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, ACTING MGR |
| Manufacturer Street | 911 HANSEN WAY M/S C-255 |
| Manufacturer City | PALO ALTO CA 94304 |
| Manufacturer Country | US |
| Manufacturer Postal | 94304 |
| Manufacturer Phone | 6504833153 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ON-BOARD IMAGER (OBI) |
| Generic Name | MEDICAL PARTICAL CHARGED RAD. THERAPY |
| Product Code | LHN |
| Date Received | 2010-01-14 |
| Model Number | H08 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2010-01-14 |