MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-08-25 for NONE CARECOM II manufactured by Executone Systems Co Of La, Inc..
[24019064]
Patient Sequence No: 1, Text Type: N, H10
[24019065]
The call bell system for approximately 20 patient rooms has been intermittently nonfunctional beginning about 2 months ago. Reportedly, when the system is activated, the room(s) calling for assistance is not shown/illuminated outside the patient room or at the nurse's desk. The system then needs to be reset after it is activated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5027567 |
| MDR Report Key | 5027567 |
| Date Received | 2015-08-25 |
| Date of Report | 2015-06-19 |
| Date of Event | 2015-05-22 |
| Report Date | 2015-06-19 |
| Date Reported to FDA | 2015-06-19 |
| Date Reported to Mfgr | 2015-06-19 |
| Date Added to Maude | 2015-08-25 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NONE |
| Generic Name | SYSTEM, ENVIRONMENTAL CONTROL, POWERED |
| Product Code | IQA |
| Date Received | 2015-08-25 |
| Model Number | CARECOM II |
| Lot Number | NONE |
| Device Availability | * |
| Device Age | 25 YR |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EXECUTONE SYSTEMS CO OF LA, INC. |
| Manufacturer Address | 1016 HARIMAW COURT EAST METAIRIE LA 70001 US 70001 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-08-25 |