MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2020-01-15 for NAVICARE PATIENT SAFETY 3.9.201 manufactured by Hill-rom Cary.
[178629326]
Based on review of the products logs, an unable to arm bed exit notification was provided to the staff console prior to the alleged fall. This notification is by design and is an indication of an issue with the bed exit.
Patient Sequence No: 1, Text Type: N, H10
[178629327]
Hillrom received a report from the account indicating the bed exit was not being properly monitored and a patient fell which resulted in an injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2027454-2020-00001 |
| MDR Report Key | 9594082 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-01-15 |
| Date of Report | 2019-12-16 |
| Date of Event | 2019-12-16 |
| Date Mfgr Received | 2019-12-16 |
| Device Manufacturer Date | 2019-08-23 |
| Date Added to Maude | 2020-01-15 |
| 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 Phone | 9198543427 |
| Manufacturer G1 | HILLROM |
| 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 | 3 |
| Brand Name | NAVICARE PATIENT SAFETY |
| Generic Name | NAVICARE PATIENT SAFETY |
| Product Code | KMI |
| Date Received | 2020-01-15 |
| Model Number | 3.9.201 |
| 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. Other | 2020-01-15 |