MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-02-17 for ERGOTRON CART SV32-32025-T manufactured by Ergotron.
[68819190]
Emergency department telestroke cart battery expanded and began to overheat. Telestroke cart removed from service and building secondary to smoke. Cart was not being on a pt at the time of the incident. Call was made to mfr and replacement battery was sent and arrived the following day and was replaced. No harm to any pts.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5068158 |
| MDR Report Key | 6363943 |
| Date Received | 2017-02-17 |
| Date of Report | 2017-02-06 |
| Date of Event | 2016-06-15 |
| Date Added to Maude | 2017-02-28 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ERGOTRON CART |
| Generic Name | CART, EMERGENCY |
| Product Code | BZN |
| Date Received | 2017-02-17 |
| Model Number | SV32-32025-T |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ERGOTRON |
| Manufacturer Address | 1181 TRAPP RD STE 100 ST. PAUL MN 55121 US 55121 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-02-17 |