MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-03-07 for XOFT AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM 110 XP1100 manufactured by Xoft, A Subsidiary Of Icad, Inc..
[4451389]
Patient was undergoing a bilateral iort brachytherapy procedure for breast cancer. During the radiation treatment of her breast, the main controller unit stopped delivering the radiation treatment. The patient received less than 95% of the prescriptive dose required. No serious injury was sustained by the patient. The treating physician indicated that the patient was scheduled for external beam radiation therapy to complete the procedure. Xoft internal tracking number: (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[11899244]
Device malfunction could not be replicated upon troubleshooting the controller unit at the customer site. It is believed that the unexpected shutdown of the unit was attributable to the old design of the high voltage cable. This component was replaced with the upgraded design. Unit was retested with no repeat occurrence of the initial malfunction.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005594788-2014-00001 |
| MDR Report Key | 3831973 |
| Report Source | 05 |
| Date Received | 2014-03-07 |
| Date of Report | 2014-03-07 |
| Date of Event | 2014-02-12 |
| Date Mfgr Received | 2014-02-12 |
| Device Manufacturer Date | 2012-12-01 |
| Date Added to Maude | 2014-06-13 |
| 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 | 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 | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | XOFT AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM |
| Generic Name | CONTROLLER |
| Product Code | JAD |
| Date Received | 2014-03-07 |
| Model Number | 110 |
| Catalog Number | XP1100 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | XOFT, A SUBSIDIARY OF ICAD, INC. |
| Manufacturer Address | SAN JOSE CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-03-07 |