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 2011-10-05 for RPM RESPIRATORY GATING SYSTEM H50 manufactured by Varian Medical Systems.
[16122216]
The customer reports that while evaluating the alignrt sys (visionrt) with rpm, they found a deviation when producing a breathing motion for the phantom and monitoring the rpm amplitude with visionrt on and off. The phantom (a polystyrene mannequin) was set up and the gating box placed the base of the sternum, the tilt of the box was no more than 10 degrees from the camera plane. There was no report of serious injury as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[16333488]
Although there was no reported injury in this case, the available info suggests a possible malfunction of the device. Though still under investigation, varian has determined that a mdr is appropriate as this possible malfunction, should it recur, could potentially result in serious injury. Add'l f/u to this mdr is expected upon completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2916710-2011-00131 |
| MDR Report Key | 2291600 |
| Report Source | 01,05,06 |
| Date Received | 2011-10-05 |
| Date of Report | 2011-09-05 |
| Date of Event | 2011-09-05 |
| Date Mfgr Received | 2011-09-05 |
| Device Manufacturer Date | 2009-11-01 |
| Date Added to Maude | 2012-07-05 |
| 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 |
| Reporter Occupation | PHYSICIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MICHAEL PIGNATARO, MGR |
| Manufacturer Street | 911 HANSEN WAY M/S C-255 |
| Manufacturer City | PALO ALTO CA 94304 |
| Manufacturer Country | US |
| Manufacturer Postal | 94304 |
| Manufacturer Phone | 6504246471 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RPM RESPIRATORY GATING SYSTEM |
| Generic Name | ACCELERATOR, LINEAR, MEDICAL |
| Product Code | IXO |
| Date Received | 2011-10-05 |
| Model Number | H50 |
| 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 | 2011-10-05 |