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 2009-12-16 for ON-BOARD IMAGER (OBI) H08 manufactured by Varian Medical Systems.
[1312247]
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, the pt was not struck.
Patient Sequence No: 1, Text Type: D, B5
[8509944]
In multiple reports of this malfunction, no serious injury has resulted, and no medical intervention beyond examination 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 examination (which was negative).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2916710-2009-00065 |
| MDR Report Key | 1575486 |
| Report Source | 01,05,06 |
| Date Received | 2009-12-16 |
| Date of Report | 2009-11-20 |
| Date of Event | 2009-11-12 |
| Date Mfgr Received | 2009-11-20 |
| Device Manufacturer Date | 2009-06-01 |
| Date Added to Maude | 2010-02-03 |
| 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 MANAGER |
| 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 | 2009-12-16 |
| Model Number | H08 |
| 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 | 2009-12-16 |