MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-09-15 for VERSACARE P3200K000500 manufactured by Hill-rom, Inc..
[86288618]
Patient Sequence No: 1, Text Type: N, H10
[86288619]
Patient in bed and alarm was set by nurse on least sensitive setting to allow the patient to sit on the edge of the bed for breakfast. The patient had previously tried to get up and the alarm had alerted staff. This is a semiprivate room and the nurse was talking to the patient in the other bed when she saw the patient begin to walk around the curtain between the patients. The patient fell straight back striking the floor. The alarm did not activate when the patient stood up. The patient was recovering from a hip fracture. This fall resulted in a secondary fracture (non-surgical) to the right femur.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6868314 |
| MDR Report Key | 6868314 |
| Date Received | 2017-09-15 |
| Date of Report | 2017-09-01 |
| Date of Event | 2017-03-15 |
| Report Date | 2017-03-31 |
| Date Reported to FDA | 2017-03-31 |
| Date Reported to Mfgr | 2017-03-31 |
| Date Added to Maude | 2017-09-15 |
| 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 | 0 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| 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 | VERSACARE |
| Generic Name | BED, FLOTATION THERAPY, POWERED |
| Product Code | IOQ |
| Date Received | 2017-09-15 |
| Model Number | P3200K000500 |
| ID Number | M05093200K0005005 |
| Device Availability | * |
| Device Age | 4 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HILL-ROM, INC. |
| Manufacturer Address | 1069 STATE ROUTE 46 EAST BATESVILLE IN 47006 US 47006 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-09-15 |