MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-11-11 for JERON 6823 manufactured by Jeron.
[5293700]
Call bell response system would not work. Maintenance came and repaired. It went offline again and jeron dual station was installed intermittent call bell response. Maintenance repaired system once and then still had to respond and replace one portion of the unit. This was 2 call lights in the same room.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5039104 |
| MDR Report Key | 4265381 |
| Date Received | 2014-11-11 |
| Date of Report | 2014-11-11 |
| Date of Event | 2014-10-15 |
| Date Added to Maude | 2014-11-21 |
| 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 | PROVIDER DUAL POWER STATION |
| Product Code | ILQ |
| Date Received | 2014-11-11 |
| Catalog Number | 6823 |
| 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 | 2014-11-11 |