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

Model Number C6804

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)

Patient Problem Death (1802)

Event Date 05/14/2016

Event Type  Death  

Manufacturer Narrative

The subscriber had been on service since 2008.There was no record of her depressing the personal help button (phb) during the event to summon help.The involved button has not been returned for evaluation as the family stated the button was not in their possession.The subscriber had a traditional (phb).This subscriber received a mailing in oct.2009 entitled, important information regarding the wearing method of your personal help button in 2009.This alerted her to the fact that any button worn around the neck poses a choking hazard and gave the subscriber the option to switch to a wrist style phb free of charge.In 2013 the subscriber received a replacement button.The caution card that ships with the button, part number 09303793, caution important safety information states, "to reduce any risk of strangulation, philips lifeline neck cords are designed to break apart under certain conditions.However, any cord worn around the neck can pose a strangulation risk, including the possibility of death and serious injuries.This may be of more concern to wearers in wheelchairs, using walkers, using beds with guard rails, or who might encounter other protruding objects upon which the cord can become tangled.Wearers for whom this is a concern may wish to consider the wristband style button." the reporter stated that the neck cord had a knot tied near the breakaway fuse.Available information supports the alteration prevented the breakaway from deploying.This appears to be a very unfortunate accident.In the event the manufacturer obtains more information regarding this event, a follow up report will be sent.Not in possession of family.

Event Description

The caller stated his mother-in-law was found with the neck cord of her personal help button (phb) entangled on her walker.He stated the neck cord appeared to have a breakaway design but a knot had been tied near the breakaway fuse.

Manufacturer Narrative

On sept.28, 2016, the manufacturer received a copy of the report of the investigation conducted by the office of the (b)(6) coroner.The report (which is in the (b)(6) language) concludes that the death in question was an accidental death.

• Brand Name: LIFELINE PERSONAL RESPONSE SYSTEM
• Type of Device: SYSTEM, COMMUNICATION, POWERED
• Manufacturer (Section D): LIFELINE SYSTEMS, INC.; 111 lawrence st.; framingham MA 01701
• Manufacturer (Section G): LIFELINE SYSTEMS, INC.; 111 lawrence st.; framingham MA 01701
• Manufacturer Contact: ingrid sawvelle ; 111 lawrence st.; framingham, MA 01701 ; 5089881079
• MDR Report Key: 5736233
• MDR Text Key: 47762442
• Report Number: 1220762-2016-00001
• Device Sequence Number: 1
• Product Code: ILQ
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: C6804
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/28/2016
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Outcome(s): Death
• Patient Age: 91 YR