FDA Adverse Event Injury Summary report: N

LIFELINE

MDR report key: 3866826 · Received June 2, 2014

Report

Report Number
MW5036520
Event Type
Injury
Date Received
June 2, 2014
Date of Event
April 1, 2014
Report Date
May 30, 2014
Manufacturer
PHILIPS
Product Code
ILQ
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
IA, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

(B)(6) JUST INSTALLED THE LATES PHILIPS LIFE LINE SYSTEM. THE ROOM UNITS DO NOT GIVE ANY INDICATION A CALL HAS BEEN MADE, MY WIFE IN THE NURSING HOME BUILDING HAS FREQUENTLY MADE CALLS THAT WERE NOT ANSWERED WHILE BEING ASSURED THAT IF SHE PRESSED THE PADDLE (SHE AND MANY RESIDENTS ARE TOO UNSTEADY TO MANAGE A PUSH BUTTON) IT WOULD BE HEARD BY STAFF. HOWEVER, PULLING ON THE PADDLE CORD SOMETIMES LOOSENS IT AT THE WALL PLUG SO NO SIGNAL IS TRANSMITTED AND THE RESIDENT HAS NO WAY OF KNOWING THERE WAS NO TRANSMISSION. ON THE WALL NEAR EVERY TOILET IS A 3X5 CALL UNIT WITH A LARGE "ALERT" IN THE CENTER. I FELL ON THE FLOOR IN MY WIFE'S BATHROOM AND REACHED OVER MY HEAD TO PRESS THE CALL UNIT. I DID THIS REPEATEDLY FOR AN HOUR AND A QUARTER UNTIL A STAFF MEMBER CAME IN FOR SOME UNRELATED REASON AND FOUND ME. IT TURNS OUT THE UPPER PART OF THE PAD TURNS THE CALL PAD OFF SO NO SIGNAL IS WAITING TO BE ANSWERED. EVEN IF IT WERE MARKED, ONE COULD NOT SELECTIVELY PUSH THE APPROPRIATE SECTION OF THE PAD WHILE LYING ON THE FLOOR. ADDITIONALLY, I WEAR A CALL PENDANT AT ALL TIMES BECAUSE I HAVE A HIGH RISK OF FALLING. THE PHILIPS SYSTEM IS ADVERTISED AS LOCATING WHERE THE PERSONAL BUTTON IS ACTIVATED AND THAT WAS THE UNDERSTANDING BY THE VILLAGE WHEN THE PURCHASE WAS MADE. WHEN I FELL IN MY WIFE'S BATHROOM, I ALSO PRESSED MY PERSONAL CALL BUTTON; WITH NO APPARENT RESULTS. IN FACT, THE CALL WAS PICKED UP BY THE SENSOR SYSTEM BUT THE INFO WAS TRANSMITTED TO THE VILLAGE MAIN OFFICE THAT THE CALL ORIGINATED IN MY APARTMENT IN MY HOME BUILDING. THIS HAS A VERY NEGATIVE EFFECT ON MY HEALTH. I WALK FOR EXERCISE AND BECAUSE OF MY FALL RISK WAS BARRED FROM WALKING FOR FEAR I WOULD FALL SOMEWHERE AND LIE THERE UNDETECTED. THE NEW SYSTEM WAS EXPECTED TO ENABLE ME TO WALK AROUND AGAIN. I AM CURRENTLY UNDER INTENSIVE MEDICAL CARE FOR PROBLEMS ATTRIBUTED TO MY LOSS OF ACTIVE MOBILITY.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
322477 LIFELINE NONE ILQ PHILIPS

Patients

Seq Age Sex Outcome Treatment
1 89 YR Other| R| S