MAUDE Adverse Event Report: PHILIPS LIFELINE; NONE

Device Problems Loose or Intermittent Connection (1371); Communication or Transmission Problem (2896); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Code Available (3191)

Event Date 04/01/2014

Event Type  Injury  

Event Description

(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.

• Brand Name: LIFELINE
• Type of Device: NONE
• Manufacturer (Section D): PHILIPS
• MDR Report Key: 3866826
• MDR Text Key: 19557430
• Report Number: MW5036520
• Device Sequence Number: 1
• Product Code: ILQ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 05/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention; Disability
• Patient Age: 89 YR
• Patient Weight: 88