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 2009-09-23 for ON-BOARD IMAGER (OBI) H08 manufactured by Varian Medical Systems.
[1178840]
It was reported that during a scheduled oncology treatment, while moving the kvd arms into position from the obi console, the kvd panel cover fell off the assembly and struck a pt in the head. The pt was observed by hosp staff and believed not to have encountered any serious injury because of the incident. No further medical attention was required other than the separate observation.
Patient Sequence No: 1, Text Type: D, B5
[8418895]
The pt's additional exam did not show evidence of any injury from the impact encountered. In multiple reports of this malfunction, no serious injury has resulted, and no medical intervention beyond exam and/or diagnostic testing has resulted. After the reported occurrence, varian service instructed the hosp's biomedical engineering dept to secure the cover to the imager with screws. This is a varian approved modification which replaces the usage to the originally designed velcro fasteners. Varian has come to a decision to report incidents involving medical intervention (x-ray and ct scans) or observations. Varian has determined that an mdr is appropriate, as this malfunction, should it recur, could potentially cause a serious injury.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2916710-2009-00039 |
| MDR Report Key | 1508175 |
| Report Source | 01,05,06 |
| Date Received | 2009-09-23 |
| Date of Report | 2009-09-08 |
| Date of Event | 2009-09-08 |
| Device Manufacturer Date | 2006-11-01 |
| 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 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 | 2009-09-23 |
| 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 | 2009-09-23 |