MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-02-03 for RPM RESPIRATORY GATING SYSTEM HXM1 manufactured by Varian Medical Systems, Inc..
[1966654]
Rpm gating - pt reference curve is not being properly displayed. Customer states that they started a left breast breath hold pt, whose films and skin verification were not even close to what their threshold was on the rpm computer. The issue appears to have begun last week, when the threshold bars came across with a large distance between the two and very little distance above the normal breathing wave. When the pt was asked to take in a breath, the breath disappeared off the top of the screen. Customer is comfortable with treating pts once they find the desired breath hold level, but are getting very frustrated with the inconsistencies of the software.
Patient Sequence No: 1, Text Type: D, B5
[8861542]
There was no reported adverse event associated with this complaint. The customer/user noticed the visual display which notified them of this issue. It is thought that all customers may not be as diligent in checking the visual display prior to treatment. Though still under investigation, varian has determined that, based on the available info, an mdr is appropriate as this possible malfunction, should it recur, could potentially cause 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 | 2916710-2011-00005 |
| MDR Report Key | 1983301 |
| Report Source | 05,06 |
| Date Received | 2011-02-03 |
| Date of Report | 2011-01-17 |
| Date of Event | 2011-01-17 |
| Date Mfgr Received | 2011-01-17 |
| Device Manufacturer Date | 2011-01-01 |
| Date Added to Maude | 2012-02-06 |
| 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 | MICHAEL PIGNATARO, MGR |
| Manufacturer Street | 911 HANSEN WAY |
| 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 | LHN |
| Date Received | 2011-02-03 |
| Model Number | HXM1 |
| ID Number | RPM 1.6 |
| 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, INC. |
| Manufacturer Address | PALO ALTO CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-02-03 |