LIFELINE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-06-02 for LIFELINE manufactured by Philips.

Event Text Entries

[19557430] (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.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5036520
MDR Report Key3866826
Date Received2014-06-02
Date of Report2014-05-30
Date of Event2014-04-01
Date Added to Maude2014-06-13
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationPATIENT
Health Professional0
Initial Report to FDA3
Report to FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameLIFELINE
Generic NameNONE
Product CodeILQ
Date Received2014-06-02
OperatorLAY USER/PATIENT
Device Sequence No1
Device Event Key0
ManufacturerPHILIPS


Patients

Patient NumberTreatmentOutcomeDate
101. Other; 2. Required No Informationntervention; 3. Deathisabilit 2014-06-02

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