MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-11-06 for EARLY RESPONSE SYSTEM 680 manufactured by Jeron.
[19402471]
The call light over head page did not operate to notify staff of code blue. The software had been tested 30 days prior. It was noted after the code by the nursing supervisor and other staff that they didn to hear an overhead page of the code blue. The rn supervisor nearby entered the room when she saw the outside siren light flashing. After the event, the supervisor was asked by the aoc to test several rooms to see if the pager system was working and it was not.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5039060 |
| MDR Report Key | 4253548 |
| Date Received | 2014-11-06 |
| Date of Report | 2014-11-06 |
| Date of Event | 2014-10-27 |
| Date Added to Maude | 2014-11-18 |
| 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 | EARLY RESPONSE SYSTEM |
| Generic Name | EARLY RESPONSE SYSTEM |
| Product Code | ILQ |
| Date Received | 2014-11-06 |
| Model Number | 680 |
| Catalog Number | 680 |
| Operator | HEALTH PROFESSIONAL |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | JERON |
| Manufacturer Address | CHICAGO IL 60660 US 60660 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-11-06 |