MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-05-28 for WESCOM PATIENT STATION MODEL MEDLINK #SPS-3000 SPS 3000 manufactured by Critical Alert, Inc. - Formerly Wescom.
[3528414]
Smoke and a "burning smell" were detected coming from a (b)(4) pt station medlink model sps-3000. Pt not effected other than moving to another room. No damage outside of wall until other than smoke and odor. A pressboard insert and the circuit board inside the unit sustained burn/melting damage.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5030363 |
| MDR Report Key | 3144870 |
| Date Received | 2013-05-28 |
| Date of Report | 2013-05-28 |
| Date of Event | 2013-04-26 |
| Date Added to Maude | 2013-06-06 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WESCOM PATIENT STATION MODEL MEDLINK #SPS-3000 |
| Generic Name | WESOM MEDLINK NURSE CALL STATION |
| Product Code | ILQ |
| Date Received | 2013-05-28 |
| Model Number | SPS 3000 |
| Operator | OTHER |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CRITICAL ALERT, INC. - FORMERLY WESCOM |
| Manufacturer Address | JACKSONVILLE FL 32216 US 32216 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-05-28 |