FDA Adverse Event Death Summary report: N

PHILIPS

MDR report key: 2583876 · Received May 16, 2012

Report

Report Number
MW5025448
Event Type
Death
Date Received
May 16, 2012
Date of Event
April 27, 2012
Report Date
May 16, 2012
Manufacturer
PHILIPS
Product Code
ILQ
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
MI, US
Reporter Occupation
NURSE

Narratives

Description of Event or Problem · 1

MY MOTHER HAD A PHILIPS LIFELINE THAT SHE WAS WEARING WHEN SHE FELL (B)(6) 2012 AND DID NOT ALARM. SHE HAD FALLEN WITH THIS DEVICE PREVIOUSLY AND IT HAD ALARMED. SHE HAD RESPONDED TO THE ATTENDANT AT HER SENIOR LIVING APARTMENT AT APPROX. 9AM STATING THAT SHE WAS OKAY. MY SISTER CALLED HER AT 10 O¿CLOCK, AND SHE DID NOT ANSWER. SHE CALLED BACK AT 10:30, BUT MOM DID NOT ANSWER. SO MY SISTER WENT TO HER APARTMENT AND ARRIVED APPROX. 11AM. MOM WAS CONSCIOUS, BUT DAZED. SHE HAD BECOME INCONTINENT, BUT WAS UNAWARE OF THAT. SHE WAS LYING ON HER BACK, BUT HAD OBVIOUSLY FALLEN AND HIT HER RIGHT FOREHEAD FORCEFULLY AGAINST SOME OBJECT. SHE HIT HARD ENOUGH TO CAUSE A CONCURRENT BLEED IN HER OCCIPITAL AREA. THE FOREHEAD WAS ALREADY QUITE BLUE AND PURPLE, INDICATING AS WELL THAT SHE HAD BEEN DOWN FOR A TIME. THE AMBULANCE WAS CALLED TO TAKE HER TO THE LOCAL HOSPITAL, AND THEN SHE WAS AIRLIFTED TO (B)(6). SHE STAYED THERE THROUGH (B)(6) 2012 AND WAS DISMISSED TO THE RED WING CARE CENTER FOR REHABILITATION. SHE DIED IN HER SLEEP THAT NIGHT. THE FAILURE OF THE LIFELINE TO ALARM AND CALL 911, AS IT IS SUPPOSED TO DO, LOST PRECIOUS TIME FOR HER CONDITION. WE HAD TRUSTED THIS DEVICE TO ALLOW HER TO BE AS INDEPENDENT AS POSSIBLE, AS THE LIFELINE WEBSITE ADVERTISES. THE DEVICE DID NOT FUNCTION AS ADVERTISED, AND MAY HAVE LED TO HER DEATH. DATES OF USE: (B)(6) 2010- (B)(6) 2012. REASON FOR USE: ALERT FOR FALLS.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 PHILIPS LIFELINE ILQ PHILIPS L6900 MAIN 2C7B

Patients

Seq Age Sex Outcome Treatment
1 06/19/1 Death