MAUDE Adverse Event Report: LIFELINE SYSTEMS, INC. LIFELINE PERSONAL RESPONSE SYSTEM; SYSTEM, COMMUNICATION, POWERED (ILQ)

Model Number 6900AT

Device Problems Use of Device Problem (1670); Activation Failure (3270)

Patient Problem Death (1802)

Event Date 06/28/2018

Event Type  Death  

Manufacturer Narrative

Per the reporter, it is unclear if the subscriber did try to depress her personal help button (phb) after the reported incident.Service records for the subscriber were reviewed.The subscriber had a traditional phb which needs to be depressed in order to signal the call center.On (b)(6) 2017 the subscriber phoned customer service and stated she had lost her phb.A replacement phb was mailed, and on aug.30, 2017 the subscriber again phoned into the customer service for help in programming her new phb.The replacement phb was successfully programmed and functional.Each phb had a distinct radiofrequency code that must be programmed to the communicator in order for it to be functional.The subscriber had a 6900at communicator which by design has an automatic test feature.Our review of maintenance signals indicates that the communicator and the replacement phb were fully functional prior to and after the event.On the evening of (b)(6) 2018 the daughter depressed the "help button" of the communicator.When the daughter spoke to the call center agent, she informed her that she had just tried to depress the phb and it did not signal the cal center.The agent assisted the daughter with programming the phb to the communicator and it successfully signalled the call center.Our conclusion after reviewing all available service records, is that the replacement phb, which had been sent to the subscriber, was not the phb being used during the reported incident.It is likely the phb used during the time of the incident was the "lost" phb from august 2017 which was no longer programmed to the communicator.

Event Description

As reported by the daughter in medwatch number, mw5078663, "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: 184059, 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.".

Manufacturer Narrative

The communicator arrived back and underwent investigation.There were no personal help button(s) returned with the communicator.The communicator underwent a series of visual examinations and functional tests.The communicator passed all visual exams and functional tests, no fault was found with the device.

• Brand Name: LIFELINE PERSONAL RESPONSE SYSTEM
• Type of Device: SYSTEM, COMMUNICATION, POWERED (ILQ)
• Manufacturer (Section D): LIFELINE SYSTEMS, INC.; 111 lawerence st.; framingham MA 01702
• Manufacturer (Section G): RESPIRONICS, INC.; 312 alvin drive; new kensington PA 15068
• Manufacturer Contact: ingrid sawvelle ; 111 lawrence st.; framingham, MA 01702 ; 5089881000
• MDR Report Key: 7841539
• MDR Text Key: 119031153
• Report Number: 1220762-2018-00002
• Device Sequence Number: 1
• Product Code: ILQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K914103
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 6900AT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/06/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/28/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: ATOVASTATIN; CALCITONIN; LISONPRIL; PROPANANOL; WARFARIN
• Patient Outcome(s): Death; Hospitalization; Disability
• Patient Age: 86 YR