N
Patient 1
MAUDE MDR 6948130
- MDR report key
- 6948130
- Report number
- 6948130
- Event key
- 0
- Event type
- 3
- Date of event
- 2017-08-29
- Date received
- 2017-10-13
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Report source
- U
- Manufacturer link flag
- N
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | HCE CUMULA | NURSE CALL | HCE (CORNELL LLC.) | ILQ | HWN 7633UA | N/A | N/A | * | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2017-10-13 | 0 |
Event Narratives#
D
Patient 1
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.