MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-10-13 for HCE CUMULA HWN 7633UA N/A manufactured by Hce (cornell Llc.).
[89279474]
Patient Sequence No: 1, Text Type: N, H10
[89279475]
When activated, the nurse call would give an audible sound only once and the dome light outside of the room would remain lit. The audible sound is supposed to continue intermittently until the call is answered.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6948130 |
| MDR Report Key | 6948130 |
| Date Received | 2017-10-13 |
| Date of Report | 2017-09-19 |
| Date of Event | 2017-08-29 |
| Report Date | 2017-08-30 |
| Date Reported to FDA | 2017-08-30 |
| Date Reported to Mfgr | 2017-08-30 |
| Date Added to Maude | 2017-10-13 |
| 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 | 3 |
| 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 | HCE CUMULA |
| Generic Name | NURSE CALL |
| Product Code | ILQ |
| Date Received | 2017-10-13 |
| Model Number | HWN 7633UA |
| Catalog Number | N/A |
| Lot Number | N/A |
| ID Number | N/A |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | 20 YR |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HCE (CORNELL LLC.) |
| Manufacturer Address | 410 GRAYSON DRIVE WINDER GA 30680 US 30680 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-10-13 |