FDA Adverse Event Malfunction Summary report: N

RN+ FALL WATCH WIRELESS SYSTEM

MDR report key: 1613065 · Received February 11, 2010

Report

Report Number: 1613065
Event Type: Malfunction
Date Received: February 11, 2010
Date of Event: November 13, 2009
Report Date: February 11, 2010
Manufacturer: NURSE ASSIST, INC
Product Code: KMI
Product Problem: Yes
Report Source: User Facility report
Reporter Location: SC, US
Reporter Occupation: RISK MANAGER

Narratives

Description of Event or Problem · 1

THE PATIENT'S BED ALARM WAS SOUNDING FROM THE ROOM ONLY. NURSE WAS OUTSIDE ROOM IN HALL WAY & HEARD ALARM. THE ALARM DID NOT SOUND AT THE NURSING STATION. THERE HAVE BEEN TWO OTHER INSTANCES NOTED BY THE STAFF THAT THE ALARM DID NOT SOUND AT THE NURSING STATION AT THE TIME IT WAS SOUNDING FROM THE PATIENT ROOM.WHEN WE CHECKED THE UNITS THEY WERE ALL FOUND NOT FULLY CHARGED AND THE OPERATOR NEVER GOT A MESSAGE ALERTING THAT THE UNIT IS NOT READY TO PROGRAM. WE BELIEVE THERE MUST BE AN ERROR MESSAGE DISPLAYED TO ALERT THE USER THAT THE UNIT IS NOT READY FOR PROGRAMMING.HEALTH PROFESSIONAL IMPRESSION:THERE IS THE POTENTIAL THAT THE NURSING STAFF'S RESPONSE TO A PATIENT AT RISK TO FALL WILL BE DELAYED BECAUSE THE ALARM SOUND & LOCATION WOULD NOT BE NOTED. AFTER REVIEWING THE USER GUIDE PROVIDED, IT IS OUR BELIEVE THAT THE INFORMATION PROVIDED IN STEP 3: PROGRAMING SIGNAL UNITS IS UNCLEAR. THE USER'S GUIDE INFORMATION WILL BE FORWARDED FOR REVIEW. MANUFACTURER RESPONSE (AS PER REPORTER) FOR PATIENT FALL ALARM SYSTEM, RN+ FALL WATCH WIRELESS SYSTEMMANUFACTURER REPRESENTATIVE HAS BEEN IN CONTACT WITH THE NURSE MANAGER. DIRECTOR OF RISK MANAGER ALSO SPOKE WITH HIM. MANUFACTURER REPRESENTATIVE IDENTIFIED THE ISSUE AS ONE OF THE STAFF HAVING NOT PROGRAMMED THE UNIT PROPERLY PRIOR TO USE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	RN+ FALL WATCH WIRELESS SYSTEM	PATIENT FALL ALARM SYSTEM	KMI	NURSE ASSIST, INC	*	*

Patients

Seq	Age	Sex	Outcome	Treatment
1	*