MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-07-29 for JERON 680 manufactured by Jeron Electronics Systems.
[4753322]
Code button had malfunction when pushed by a patient - repairs had been made the day prior. Malfunctioned with actual code situation on (b)(6) 2014. Code called overhead via phone system. Company called for repair. Repairs had been made previously due to an incident where the call light button was not audible and found to be an issue with the installation of the call system by the vendor.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5037537 |
| MDR Report Key | 3973010 |
| Date Received | 2014-07-29 |
| Date of Report | 2014-07-28 |
| Date of Event | 2014-07-21 |
| Date Added to Maude | 2014-08-04 |
| 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 | 2014-07-29 |
| Model Number | 680 |
| ID Number | AGE - 3 MONTHS |
| Operator | LAY USER/PATIENT |
| 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 | 1. Hospitalization | 2014-07-29 |