FDA.reportPublic FDA data

MAUDE MDR 7731039

MDR report key
7731039
Report number
MW5078663
Event key
0
Event type
3
Date of event
2018-06-28
Date received
2018-07-27
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1PHILIPS LIFELINESYSTEM, COMMUNICATION, POWEREDPHILIPS / LIFELINE SYSTEMS, INC.ILQ6900ATI *

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-07-2701. D; 2. H; 3. L; 4. S

Event Narratives#

D

Patient 1

I FOUND MY MOM ON HER BEDROOM FLOOR, BARELY CONSCIOUS WITH HER PHILLIPS LIFE ALERT PORTABLE AROUND THE NECK BUTTON BY HER SIDE. LATER THAT EVENING, I WENT TO HER HOME AND PUSHED HER BUTTON TO GET NO ANSWER FROM THE LIFE ALERT STAFF. I THEN PUSHED THE MAIN BOX/. ALTHOUGH IT IS CLEAR, WHEN THE NECK BUTTON WAS PUSHED, NO SIGNAL WENT TO PHILLIPS. BUT, BECAUSE I WAS NOT PHYSICALLY THERE, I CANNOT KNOW FOR SURE THAT SHE PUSHED IT. ALL SIGNS SHOW THAT SHE MAY HAVE TRIED, BUT I WAS NOT THERE. THE BUTTON WAS WITH HER WHEN I FOUND HER. THE MAIN UNIT ON HER NIGHT STAND DID WORK, WHICH I TRIED LATER THAT NIGHT AFTER I REALIZED THE NECK BUTTON DID NOT WORK. THAT'S WHEN THE REP TOLD ME THE NECK BUTTON WAS NOT ACTIVATED. ASSY: 1840549, MFG DATE: 02/28/2012, REV: 02, FCC ID: BDZ6200, IC:655C-6700, IC:655C-6700, R DATE: 03/03/2015, L6900AT, BARCODE: (B)(4). NECK BUTTON WAS NOT ACTIVATED THEREFORE NO CALL WAS PLACED TO PHILLIPS.