| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | STANLEY HEALTHCARE | M200 | STANLEY SECURITY SOLUTIONS, INC. | KMI | M200 | M200 | Y | R |
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2018-06-01 | 0 | 1. O |
Patient 1
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 1
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.