MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-19 for TRANSCRANIAL MAGNETIC STIMULATION MACHINE 104 manufactured by Brainsway Ltd..
[142752932]
Mcu errors when logging off and during treatment; techs say it is a known continuing issue. On (b)(6) 2019 at 10:30 am, mcu error appeared when attempting to log off machine after treatment. On (b)(6) 2019 at 8:45 am - mcu error during pt's treatment. Only completed 17 mins of treatment. On (b)(6) 2019 at 3:25 pm, mcu error right before starting pt's treatment, was able to restart machine and have uninterrupted treatment. On (b)(6) 2019, first pt of the day - machine shut down 3 times before staying on long enough to start treatment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5086032 |
| MDR Report Key | 8536049 |
| Date Received | 2019-04-19 |
| Date of Report | 2019-03-28 |
| Date of Event | 2019-03-27 |
| Date Added to Maude | 2019-04-22 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | TRANSCRANIAL MAGNETIC STIMULATION MACHINE |
| Generic Name | TMS MACHINE / TRANSCRANIAL/ MAGNETIC STIMULATOR |
| Product Code | OBP |
| Date Received | 2019-04-19 |
| Model Number | 104 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BRAINSWAY LTD. |
| Brand Name | TRANSCRANIAL MAGNETIC STIMULATION MACHINE |
| Generic Name | TMS MACHINE / TRANSCRANIAL/ MAGNETIC STIMULATOR |
| Product Code | OBP |
| Date Received | 2019-04-19 |
| Model Number | 104 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | BRAINSWAY LTD. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-04-19 |