FDA Adverse Event Malfunction Summary report: N

HUGS INFANT PROTECTION SYSTEM

MDR report key: 2592476 · Received May 21, 2012

Report

Report Number
MW5025529
Event Type
Malfunction
Date Received
May 21, 2012
Date of Event
January 5, 2012
Report Date
May 21, 2012
Manufacturer
STANLEY HEALTHCARE SOLUTIONS
Product Code
ILQ
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
FL, US
Reporter Occupation
BIOMEDICAL ENGINEER

Narratives

Description of Event or Problem · 1

DURING RENOVATION OF OUR MOTHER BABY UNIT, IT WAS DISCOVERED THAT THE LED LIGHTING BEING INSTALLED WAS CAUSING SIGNIFICANT INTERFERENCE WITH THE HUGS INFANT SECURITY SYS. THE INTERFERENCE WAS SO SEVERE THAT IT EFFECTIVELY DISABLED THE SYS POSSIBLY ALLOWING INFANT ABDUCTION TO GO UNNOTICED. A 24 HOUR SECURITY WATCH WAS ESTABLISHED WHILE THE PROBLEM WAS BEING ANALYZED AND RESOLVED. BETWEEN (B)(6) 2012, BOTH CLINICAL ENGINEERING, FACILITIES OPERATIONS AND FACILITIES DEVELOPMENT REVIEWED THE CAUSE OF THE PROBLEM AND DIFFERENT SOLUTIONS FOR THE PROBLEM. LITHONIA WAS CONTACTED AND CAME ON SITE TO POSSIBLY REMEDIATE THE PROBLEM. LITHONIA SUGGESTED A SERIES OF RESOLUTIONS THAT INCLUDED RF TAPE ON ENCLOSURES, RF BEADS FOR WIRE STRANDS, RF IRON CORE CHOKES FOR CABLES, RF FILTERS ON LOW VOLTAGE WIRING, THE POSITION OF WIRING FOR THE LOW VOLTAGE WIRING (PERPENDICULAR AND NOT PARALLEL TO THE FIXTURE) AND LOW VOLTAGE WIRING COILING (Z FOLD AND NOT COILED). ALL OF THESE MEASURES WERE IMPLEMENTED AND RESULTED IN A BEST EFFORT RF NOISE FLOOR OF -90 DB. AT THE CONCLUSION OF THE PROJECT 3 ADD'L LED FIXTURES WERE TESTED FOR RF NOISE. FINELITE AND MAXLITE HAD ALMOST NO RF NOISE AND CREE INCREASED THE NOISE FLOOR BY 10 DB. DUE TO THE -90 DB NOISE FLOOR, STANLEY HEALTHCARE SOLUTIONS HAD TO INCREASE THE DESIGN NUMBER OF RECEIVES FROM 10 TO 24 AND HAD TO INCREASE THE NUMBER OF PORTAL EXCITERS FROM 1 TO 3 PER DOOR. THESE INCREASED COSTS ADDED TO THE OVERALL PROJECT COST. IT WAS DISCOVERED THAT THE LITHONIA LIGHTING RTLX AND RTLEDDR 2 X 4 LIGHTING FIXTURES EMITTED EGREGIOUSLY HIGH LEVELS OF RADIO-FREQUENCY NOISE FROM 100 MHZ OF 300 MHZ WHICH AFFECTED THE STANLEY HEALTHCARE SOLUTIONS HUGS SYS THAT USES 217 MHZ AS ITS ACTIVE FREQUENCY. THE RF NOISE FLOOR PRESENT WITHOUT THE LITHONIA PRODUCTS WAS AT -103 DB. WITH THE LITHONIA PRODUCTS ILLUMINATED (AT ANY LEVEL) THE RF NOISE FLOOR INCREASED TO -80 DB.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 HUGS INFANT PROTECTION SYSTEM INFANT ABDUCTION SYSTEM ILQ STANLEY HEALTHCARE SOLUTIONS HUGS

Patients

Seq Age Sex Outcome Treatment
1 Other