MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2008-08-28 for RPM RESPIRATORY GATING H50 manufactured by Varian Medical Systems.
[947004]
The customer reported, "a plan is created on the ct dataset of the pt in a certain respiratory phase (deep inspiration breath hold in our case). The toggle "use gated" in the general tab of the plan properties (in eclipse or even in rt-chart) is on. The plan is loaded in the 4d itc. If the key of the rpm system (the box enabling the usage of the gating system) is in the position gating disabled, the plan is treatable! In other words, there is no interlock preventing the irradiation of the plan supposed with gating (as per the toggle "use gated"). A pt was mis-administered. "
Patient Sequence No: 1, Text Type: D, B5
[8193202]
Other: based on the initial report, varian's medical advisor was not able to render a medical evaluation on whether this event may have caused or contributed to a serious injury, or would be likely to cause or contribute to a death or serious injury if the malfunction were to recur. Though still under investigation, varian has determined that a mdr is appropriate. Additional follow-up to this mdr is expected upon completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2916710-2008-00039 |
| MDR Report Key | 1139550 |
| Report Source | 05,06 |
| Date Received | 2008-08-28 |
| Date of Report | 2008-07-21 |
| Date of Event | 2008-07-10 |
| Date Mfgr Received | 2008-07-21 |
| Device Manufacturer Date | 2006-07-01 |
| Date Added to Maude | 2008-09-04 |
| 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 |
| Manufacturer Street | 911 HANSEN WAY |
| 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 | RPM RESPIRATORY GATING |
| Generic Name | ECG/RESPIRATOR |
| Product Code | IXO |
| Date Received | 2008-08-28 |
| Model Number | H50 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1156238 |
| Manufacturer | VARIAN MEDICAL SYSTEMS |
| Manufacturer Address | PALO ALTO CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2008-08-28 |