MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2009-04-08 for AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM 110 XP1100 manufactured by Xoft, Inc..
[1190477]
During an intra-operative radiation treatment (iort) in the breast a no coolant flow error was detected in the controller. The treatment was stopped. The controller was repaired by replacing the cooling pump and the controller was restored to full function. The patient returned to the office 48 hours later and the treatment was resumed. The patient was treated successfully, and the incident did not result in a patient injury.
Patient Sequence No: 1, Text Type: D, B5
[8275207]
Supplier has been issued a corrective action to redesign the coolant pump in order to avoid future failures. Patient was not harmed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005594788-2009-00002 |
| MDR Report Key | 1429600 |
| Report Source | 05,06 |
| Date Received | 2009-04-08 |
| Date of Report | 2009-04-08 |
| Date of Event | 2009-03-13 |
| Date Mfgr Received | 2009-03-13 |
| Device Manufacturer Date | 2008-06-01 |
| Date Added to Maude | 2010-02-02 |
| 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 | STEVE LIN |
| Manufacturer Street | 345 POTRERO AVE. |
| Manufacturer City | SUNNYVALE CA 94085 |
| Manufacturer Country | US |
| Manufacturer Postal | 94085 |
| Manufacturer Phone | 4084192341 |
| Single Use | 3 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM |
| Generic Name | X-RAY RADIATION THERAPY SYSTEM |
| Product Code | JAD |
| Date Received | 2009-04-08 |
| 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, INC. |
| Manufacturer Address | 345 POTRERO AVE SUNNYVALE CA 94085 US 94085 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2009-04-08 |