MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2014-05-02 for PROBEAM PROTON THERAPY SYSTEM manufactured by .
[4641891]
The system delivered part of the prescribed treatment dose when a system interlock occurred. When the system was reset, the customer observed that the treatment console did not show the partially delivered dose.
Patient Sequence No: 1, Text Type: D, B5
[12051136]
Based on our preliminary investigation: an unrecoverable system interrupt occurred during a patient treatment and the treatment record was not automatically written back to the oncology information system (ois). The user manually inputted the treatment record into the ois. In this case, the ois assumed that the partially delivered dose was administered in the order prescribed in the treatment planning system. Since the scanning system re-orders the spots, this could lead to the wrong spot distribution in the affected layer. This event did not result is a misadministration or a patient harm. This failure mode could potentially cause harm if the interruption were to occur during a stereo-tactic treatment. Please note there is only one probeam site (device) in the u. S. There have been no stereo-tactic treatments planned or conducted, and there are no immediate plans to perform this treatment modality at this facility. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3008889206-2014-00001 |
| MDR Report Key | 3949376 |
| Report Source | 05,06 |
| Date Received | 2014-05-02 |
| Date of Report | 2014-04-02 |
| Date of Event | 2014-04-02 |
| Date Mfgr Received | 2014-04-02 |
| Device Manufacturer Date | 2014-02-01 |
| Date Added to Maude | 2014-07-30 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | RAID AFANA |
| Manufacturer Street | FRIEDRICH-EBERT-STR.1 |
| Manufacturer City | BERGISCH GLADBACH D-51429 |
| Manufacturer Country | GM |
| Manufacturer Postal | D-51429 |
| Manufacturer Phone | 3214427 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PROBEAM PROTON THERAPY SYSTEM |
| Generic Name | SYSTEM, RADIATION THERAPY |
| Product Code | LHN |
| Date Received | 2014-05-02 |
| Model Number | PROBEAM |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-05-02 |