MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-05-02 for NEUROSTAR * manufactured by Neuronetics Inc..
[19267250]
At the start of transcranial magnetic stimulation treatment using the neuronetics neurostar mobile tms console, the touchscreen display interface froze. The clinician was unable to adjust the headpiece to begin the treatment. Patient was asked to leave and return at a later time for treatment. ====================== manufacturer response for transcranial magnetic stimulation touch screen, neurostar (per site reporter)======================manufacturer sent repair person as part of maintenance contract, failed touchscreen was replaced. Several days after touchscreen replacement, similar "frozen screen" occurred. Manufacturer rep contacted and indicates possible issue with corded connection to mobile console.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2077939 |
| MDR Report Key | 2077939 |
| Date Received | 2011-05-02 |
| Date of Report | 2011-04-25 |
| Date of Event | 2011-04-21 |
| Report Date | 2011-04-25 |
| Date Reported to FDA | 2011-05-02 |
| Date Added to Maude | 2011-05-05 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NEUROSTAR |
| Generic Name | REPETITIVE TRANSCRANIAL MAGNETIC STIMULATOR FOR TREATMENT OF |
| Product Code | OBP |
| Date Received | 2011-05-02 |
| Returned To Mfg | 2011-04-22 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | NURSE |
| Device Availability | R |
| Device Age | 3 YR 2 MO |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NEURONETICS INC. |
| Manufacturer Address | 31 GENERAL WARREN BLVD MALVERN PA 19355124 US 19355 1245 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-05-02 |