MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-05-20 for AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM 100 X1000 manufactured by Xoft, A Subsidiary Of Icad, Inc..
[45626028]
Manufacturer failure analysis: the e102 error code as reported by the facility is attributed to a power interrupt during boot-up or a signal loss occurring between the controller and its electrometer. The error state is cleared by the application of the usb service key, which the operator did not have in the vicinity of the controller, thus delaying the procedure. Additional delay in the procedure occurred by the operator not following the recovery instructions as provided in the controller troubleshooting guide until instructed by xoft field service. The e221 error code is a fault condition attributed to a bad x-ray source. Under such condition, the troubleshooting guide instructs the operator to replace the device, which was the action taken by the facility. The indicated failure poses no risk to the safety of the patient, as the condition is detected during the device calibration before active therapy is delivered to the patient.
Patient Sequence No: 1, Text Type: N, H10
[45626029]
A patient undergoing brachytherapy treatment for breast cancer experienced a delay in the procedure due to the brachytherapy controller system registering an e102 error code during the system boot-up and the operator (or treating facility) not following the recovery instructions as advised for restoring the system. The facility contacted xoft field service to intervene in the troubleshooting. Field service advised the operator to use the usb service key provided with the controller to restore the system. Upon receiving instruction, the operator could not locate the key and was required to retrieve the device from another location in the facility while the patient remained under anesthesia. Once retrieved, the device was used as instructed by field service and the controller was restored. During the next step of the process, the operator encountered an e221 error code during the calibration of the x-ray source, at which point, was advised by xoft field service to replace the device with a second source. The second device calibrated with no further incident, and the patient's procedure was completed. No serious injury to the patient was confirmed. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[45822047]
This report is a follow-up to mdr # 3005594788-2016-00001. The date of event previously reported is incorrect. The correct date of event is (b)(6) 2016. All other information as previously reported is unchanged.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005594788-2016-00001 |
| MDR Report Key | 5670202 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-05-20 |
| Date of Report | 2016-04-29 |
| Date of Event | 2016-04-29 |
| Date Mfgr Received | 2016-04-29 |
| Device Manufacturer Date | 2008-09-02 |
| Date Added to Maude | 2016-05-20 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. AL YOUNG |
| Manufacturer Street | 101 NICHOLSON LANE |
| Manufacturer City | SAN JOSE CA 95134 |
| Manufacturer Country | US |
| Manufacturer Postal | 95134 |
| Manufacturer Phone | 4084931541 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM |
| Generic Name | CONTROLLER |
| Product Code | JAD |
| Date Received | 2016-05-20 |
| Model Number | 100 |
| Catalog Number | X1000 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | XOFT, A SUBSIDIARY OF ICAD, INC. |
| Manufacturer Address | 101 NICHOLSON LANE SAN JOSE CA 95134 US 95134 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-05-20 |