MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06,07 report with the FDA on 2010-08-02 for ACUITY H77-SIM manufactured by Varian Medical Systems.
[1629253]
The customer reported that when applying the instructions from the customer technical bulletin, the mlc was still mirrored incorrectly and was not able to prevent the problem. The customer alleges, "when all tests were performed all those tests (which ultimately lead to the ctb), i did enter the target value manually and then moved the collimator to the desired angle. By doing so i found that problem occurs between 315 degrees and 359. 9 degrees. Reading the ctb, it seems that one can overcome the problem by overwriting the value in the field properties. After having moved the collimator to target position (because it might stop at a value with multiple decimals that aren't displayed? ), i tried that with a field where i set the collimator to exactly 359. 0 degrees in the field properties. The collimator of the opposing field was then 1. 0 degree, but the mlc was still mirrored wrongly. I tried changing the value before and after image acquisition. (does image acquisition have anything to do with it? ) ,in any case, i wasn't able to prevent the problem. " no serious injury to the patient was reported and no patient data provided.
Patient Sequence No: 1, Text Type: D, B5
[8684034]
It is standard clinical practice to acquire portal images on the first day of treatment. These images are reviewed and approved by the physician prior to starting treatment for single fraction treatments and typically before the second fraction for multiple fraction courses. Any misplacement of the mlc should be identified prior to treatment and if not then during physician image review following the first treatment fraction. Thus, the patient would likely be treated for at most a single fraction with incorrect mlc. In this case there was no report of serious injury. In order to mitigate recurrence of this issue for current acuity users, a customer technical bulletin (ctb) was provided to further describe the behavior and instruct on the available workaround. However, in this case the mlc was still mirrored incorrectly and the user was not able to prevent the problem. Though still under investigation, varian has determine that a mdr is appropriate, as this malfunction, should it recur, could potentially cause a serious injury. Additional follow-up to this mdr is expected upon completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8020711-2010-00007 |
| MDR Report Key | 1794025 |
| Report Source | 01,05,06,07 |
| Date Received | 2010-08-02 |
| Date of Report | 2010-07-01 |
| Date of Event | 2010-07-01 |
| Date Mfgr Received | 2010-07-01 |
| Device Manufacturer Date | 2004-11-01 |
| Date Added to Maude | 2012-01-05 |
| 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 |
| 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 | 7029384800 |
| Manufacturer G1 | VARIAN MEDICAL SYSTEMS UK LTD. |
| Manufacturer Street | GATWICK RD. |
| Manufacturer City | CRAWLEY, WEST SUSSEX RH1094G |
| Manufacturer Country | UK |
| Manufacturer Postal Code | RH10 94G |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACUITY |
| Generic Name | SIMULATOR |
| Product Code | KPQ |
| Date Received | 2010-08-02 |
| Model Number | H77-SIM |
| ID Number | V8.9 |
| 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 | PALTO ALTO CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-08-02 |