MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-08-04 for JERON 680 manufactured by Jeron Electronics Systems.
[4635397]
Call system malfunction when code blue called in room (b)(6). Code button pressed - no visual or audible alarm in hallway, no announcement overhead. Icu nurses did note the blue flashing light on the panel in icu. Code was called via phone. Fyi: 2 additional events ((b)(6)) on (b)(6) where the call lights worked outside the rooms, but the phone console at the main nursing station not working - unable to speak to patients and unable to tell the room calling. Repair company called. Also see reports mw5037646 and mw5037647.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5037645 |
| MDR Report Key | 3986920 |
| Date Received | 2014-08-04 |
| Date of Report | 2014-08-01 |
| Date of Event | 2014-07-29 |
| Date Added to Maude | 2014-08-12 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 | JERON |
| Generic Name | CALL SYSTEM |
| Product Code | ILQ |
| Date Received | 2014-08-04 |
| Model Number | 680 |
| ID Number | AGE APPROXIMATELY 3 MONTHS |
| Operator | HEALTH PROFESSIONAL |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | JERON ELECTRONICS SYSTEMS |
| Manufacturer Address | CHICAGO IL 60660 US 60660 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-08-04 |