MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2015-01-20 for TARGIS SYSTEM RB3131A manufactured by Urologix, Inc..
[5377057]
It was reported to field service that there was an interruption in ac power at the treating facility about 15 minutes into a procedure. The control unit re-initialized after the interruption in power and staff initiated the treatment restart option. During the restart phase there was a second interruption in ac power. The unit again re-initialized and remained in the restart phase however the phase did not complete indicating that the system was not ready to recalibrate and continue treatment. At this time the coolant temperature was checked and the coolant was found to be hot to the touch. The control unit was turned off and then back on, and it displayed a coolant error message. At this point the procedure was stopped. There was no injury to the patient. After the procedure was ended field service had the technician check the control unit internal coolant level and cooling system operation in the debug mode using a coolant bag. The control unit cooling system operated without any errors in the debug mode with a coolant bag for better than fifteen minutes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2133936-2015-00001 |
| MDR Report Key | 4434244 |
| Report Source | 05 |
| Date Received | 2015-01-20 |
| Date of Report | 2015-01-16 |
| Date of Event | 2014-12-19 |
| Date Mfgr Received | 2014-12-19 |
| Date Added to Maude | 2015-02-23 |
| 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 | MARGARET BATCHELDER |
| Manufacturer Street | 14405 21ST AVENUE N |
| Manufacturer City | MINNEAPOLIS MN 55447 |
| Manufacturer Country | US |
| Manufacturer Postal | 55447 |
| Manufacturer Phone | 7634751400 |
| Manufacturer G1 | UROLOGIX, INC. |
| Manufacturer Street | 14405 21ST AVENUE N |
| Manufacturer City | MINNEAPOLIS MN 55447 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55447 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TARGIS SYSTEM |
| Generic Name | MICROWAVE DELIVERY SYSTEM |
| Product Code | MEQ |
| Date Received | 2015-01-20 |
| Model Number | RB3131A |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UROLOGIX, INC. |
| Manufacturer Address | 14405 21ST AVENUE N MINNEAPOLIS MN 55447 US 55447 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-01-20 |