MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-06-01 for STANLEY HEALTHCARE M200 manufactured by Stanley Security Solutions, Inc..
[109899384]
We believe the root cause of the fall is the fact that monitor was not armed properly and that the nurse call cord being plugged incorrectly into the pad jack by staff inadvertently damaged the pins of the jack. Our course of action is to always improve our product, but the bottom line is, had the facility followed the steps taught by the partner the monitor would have alarmed.
Patient Sequence No: 1, Text Type: N, H10
[109899385]
Nurse placed patient in a bedside chair. There was a chair pad connected to the m200, with a paper "chuck" between the pad and patient. The nurse heard the monitor beep as the patient sat down indicating it was monitoring the patient. The m200 was connected to the nurse call system (they do not use the power adaptors). A tech, performing hourly rounding, walked in the room and found the patient on the floor, the m200 was not alarming and there were no alerts through their nurse call phones. During the post fall huddle, the nurse tested the pad and monitor by pressing on the pad. She stated it took her 3 tries of placing pressure on the pad to receive the activation beep however on removal of pressure the m200 did not alarm. They do not perform regular checks on the m200, this is a new product for them within the last several months. They had previsouly used out tabs fall monitors. (b)(6). Report number -- mw5077240. Pt was assisted to the chair. When nursing staff went to check on patient he was found on the floor. Chair alarm was noted to malfunction after testing and did not sound as expected when patient attempted to get up. Patient with hip fracture requiring surgical intervention.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1929691-2018-00002 |
| MDR Report Key | 7560676 |
| Report Source | USER FACILITY |
| Date Received | 2018-06-01 |
| Date of Report | 2018-05-19 |
| Date of Event | 2018-03-16 |
| Report Date | 2018-02-23 |
| Date Reported to Mfgr | 2018-02-23 |
| Date Mfgr Received | 2018-03-28 |
| Device Manufacturer Date | 2016-07-28 |
| Date Added to Maude | 2018-06-01 |
| 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 Contact | MS GINA BENNETT |
| Manufacturer Street | 4600 VINE STREET |
| Manufacturer City | LINCOLN NE 68503 |
| Manufacturer Country | US |
| Manufacturer Postal | 68503 |
| Manufacturer Phone | 4027429335 |
| Manufacturer G1 | STANLEY SECURITY SOLUTIONS, INC |
| Manufacturer Street | 4600 VINE STREET |
| Manufacturer City | LINCOLN NE 68503 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 68503 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STANLEY HEALTHCARE |
| Generic Name | M200 |
| Product Code | KMI |
| Date Received | 2018-06-01 |
| Returned To Mfg | 2018-04-11 |
| Model Number | M200 |
| Catalog Number | M200 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 2 YR |
| Device Eval'ed by Mfgr | Y |
| 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 | 2018-06-01 |