MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-15 for MONITOR, BED PATIENT manufactured by Hill-rom, Inc..
[145091246]
Patient found on floor, unwitnessed. Nurse anesthetist observed the patient on floor; and when staff assisted patient to bed it was identified that the bed alarm was on however not sounding. Patient assisted into new bed; and previous bed noted was red tagged for occurrence.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8611465 |
| MDR Report Key | 8611465 |
| Date Received | 2019-05-15 |
| Date of Report | 2019-04-12 |
| Date of Event | 2019-04-11 |
| Report Date | 2019-04-12 |
| Date Reported to FDA | 2019-04-12 |
| Date Reported to Mfgr | 2019-05-15 |
| Date Added to Maude | 2019-05-15 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 |
| Generic Name | MONITOR, BED PATIENT |
| Product Code | KMI |
| Date Received | 2019-05-15 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HILL-ROM, INC. |
| Manufacturer Address | 1225 CRESCENT GREEN DR. SUITE 300 CARY NC 27518 US 27518 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-15 |