MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-30 for NAVICARE NURSE CALL NNC 3.6.600 manufactured by Hill-rom Cary.
[94279697]
Hill-rom investigation determined the patient room was offline at the time of the reported event. The appropriate system alerts were present on the system in the room and at the nurse? S station indicating the room was offline. A review of the log files indicates a nurse was present in the room for 1 1/2 minutes prior to pulling the code blue lever with two additional staff members entering the room prior to pulling the code blue lever. The staff remained in the room at the time the device did not ring remotely at the primary nurse station. Hill-rom requested the return of the room control board for investigation. The user facility declined to release the room control board. Investigation to date indicates the control board for the room as the potential cause of the room dropping off line. If additional information becomes available during our investigation, a follow up report will be filed.
Patient Sequence No: 1, Text Type: N, H10
[94279698]
Hill-rom received a report from the account stating the code blue lever was pulled but that the call was delayed in ringing at the primary nurse station.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2027454-2017-00001 |
| MDR Report Key | 7073275 |
| Date Received | 2017-11-30 |
| Date of Report | 2017-10-31 |
| Date of Event | 2017-10-22 |
| Date Mfgr Received | 2017-10-31 |
| Device Manufacturer Date | 2016-12-01 |
| Date Added to Maude | 2017-11-30 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR GEOFF GORHAM |
| Manufacturer Street | 1225 CRESCENT GREEN DR., SUITE 300 |
| Manufacturer City | CARY NC 27518 |
| Manufacturer Country | US |
| Manufacturer Postal | 27518 |
| Manufacturer G1 | HILL-ROM |
| Manufacturer Street | 1225 CRESCENT GREEN DR., SUITE |
| Manufacturer City | CARY NC 27518 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 27518 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | NAVICARE NURSE CALL |
| Generic Name | NAVICARE NURSE CALL |
| Product Code | ILQ |
| Date Received | 2017-11-30 |
| Model Number | NNC 3.6.600 |
| Operator | NURSE |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HILL-ROM CARY |
| Manufacturer Address | 1225 CRESCENT GREEN DR., SUITE 300 CARY NC 27518 US 27518 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2017-11-30 |