MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-06 for BED CHECK 72100 14082705C1 manufactured by Stanley Security Solutions.
[113642687]
Re: medwatch form (b)(4). Dear (b)(6), on 1/8/2018, stanley healthcare (sh) received a medwatch report from your facility reporting device malfunctions. You reported an incident having occurred on approximately (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. In the past, our company has sent compliance, engineering and product solutions staff to your facility to discuss recurring issues and observe the system in use. We have provided suggested best practices for your staff to adhere to ensuring our product is used properly. As my calls and emails have not been returned - i am closing out this filing citing no further action required by stanley healthcare. 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), director of compliance. [(b)(4)].
Patient Sequence No: 1, Text Type: N, H10
[113642688]
Patient was placed on chair with chair check inplace and activated. Five minutes later, patient slid from chair to the floor and the chair check did not alarm. The patient suffered no injuries.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1929691-2018-00007 |
| MDR Report Key | 7667663 |
| Date Received | 2018-07-06 |
| Date of Report | 2017-09-08 |
| Date of Event | 2017-09-03 |
| Report Date | 2017-09-15 |
| Date Reported to FDA | 2017-09-15 |
| Date Mfgr Received | 2017-10-02 |
| Device Manufacturer Date | 2016-03-04 |
| Date Added to Maude | 2018-07-06 |
| 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 | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. GARTH JACK |
| Manufacturer Street | 4600 VINE STREET |
| Manufacturer City | LINCOLN NE 68503 |
| Manufacturer Country | US |
| Manufacturer Postal | 68503 |
| Manufacturer Phone | 4027429335 |
| Manufacturer G1 | STANLEY SECURITY SOLUTIONS |
| Manufacturer Street | 4600 VINE STREET |
| Manufacturer City | LINCOLN NE 68503 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 68503 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BED CHECK |
| Generic Name | MONITOR BED PATIENT |
| Product Code | KMI |
| Date Received | 2018-07-06 |
| Model Number | 72100 |
| Catalog Number | 14082705C1 |
| Device Availability | N |
| Device Age | 1 YR |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STANLEY SECURITY SOLUTIONS |
| Manufacturer Address | 4600 VINE STREET LINCOLN NE 68503 US 68503 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-07-06 |