MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-19 for 14-DAY SENSORMAT PAD 73030 manufactured by Stanley Security Solutions, Inc..
[120964054]
Elderly male with confusion/disorientation had fall-precautions in place. Patient got up to go to the bathroom and chair alarm did not go off (set as alarmed and activated under patient). Tested and still did not work, so a new one was set up and tested ok. Patient sustained 4 skin tears to left arm, bruise/contusion. Fall precautions include the following in place at time of fall: bed in low position, bed table in reach, call bell in reach, call light/phone/bedpan/other personal items in reach, caution signs in place, chair alarm, fall alert , hourly (or more frequent) comfort and toileting rounds, light/night light on, non-slip footwear, patient family education, patient situated close to nurse's station, physician/occupational thx, use of gait belt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7890716 |
| MDR Report Key | 7890716 |
| Date Received | 2018-09-19 |
| Date of Report | 2018-08-30 |
| Date of Event | 2018-08-15 |
| Report Date | 2018-08-30 |
| Date Reported to FDA | 2018-08-30 |
| Date Reported to Mfgr | 2018-09-19 |
| Date Added to Maude | 2018-09-19 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| 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 | 0 |
| Brand Name | 14-DAY SENSORMAT PAD |
| Generic Name | MONITOR, BED PATIENT |
| Product Code | KMI |
| Date Received | 2018-09-19 |
| Model Number | 73030 |
| Device Availability | Y |
| Device Age | 0 YR |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STANLEY SECURITY SOLUTIONS, INC. |
| Manufacturer Address | 4600 VINE ST. LINCOLN NE 68503 US 68503 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-09-19 |