MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-13 for BED-CHECK 74030 manufactured by Stanley Security Solutions, Inc..
[108498544]
Dear (b)(4), on 9/23/2017, (b)(4) received a medwatch report from your facility reporting device malfunctions. You reported an incident having occurred on (b)(6) 2017. No injury was reported in the mdr filing. To date, none of the reported equipment has been returned to sh for further evaluation as requested. As my calls and emails have not been returned - i am closing out this filing citing no further action required by (b)(4). I would like to remind you of the following warning statements in the bed-check? Cordless user guide: - test the bed-check? Monitor and sensormat? Pad before each use and inspect the cords and pads for signs of damage. Replace any components with signs of wear or damage immediately. - check that the transmitter is switched on and that the status led on the monitor flashes green for at least 1 second when the reset button is pressed, or the status led flashes green for 0. 5 seconds once per minute to indicate that it is monitoring the person. - operators of this equipment must be familiar with the functions and usage as described in this manual, and must be properly trained in the patient care policies and procedures of the facility. If you have any questions, please feel free to contact me at (b)(4). Sincerely, (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[108498545]
Patient left floor to meet son who was waiting for her for discharge. The chair alarm did not go off to notify staff she was getting up.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1929691-2018-00001 |
| MDR Report Key | 7509785 |
| Date Received | 2018-05-13 |
| Date of Report | 2017-06-06 |
| Date of Event | 2017-02-15 |
| Report Date | 2017-06-15 |
| Date Reported to FDA | 2017-06-15 |
| Date Mfgr Received | 2017-06-29 |
| Date Added to Maude | 2018-05-13 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | 4600 VINE STREET |
| Manufacturer City | LINCOLN NE 68503 |
| Manufacturer Country | US |
| Manufacturer Postal | 68503 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BED-CHECK |
| Generic Name | BED PATIENT MONITOR, PRODUCT CODE: KMI |
| Product Code | KMI |
| Date Received | 2018-05-13 |
| Model Number | 74030 |
| Catalog Number | 74030 |
| Lot Number | B0816 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STANLEY SECURITY SOLUTIONS, INC. |
| Manufacturer Address | 4600 VINE STREET LINCOLN NE 68503 US 68503 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-05-13 |