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

Model Number FD100

Device Problem Insufficient Information (3190)

Patient Problem Fall (1848)

Event Type  Injury  

Manufacturer Narrative

As reported to fda per 1220762-11-15-2017-001-r, the involved button is part of a field action on the part of the manufacturer.The involved button did not have the appropriate fall parameters.It is unclear from the information provided to the manufacturer if the button may have contributed to any injury the subscriber sustained.The involved button was still able to be depressed to summon help.Per autoalert help button, instructions for use (p/n 0940718 rev.7) p.10 the autoalert help button can detect most falls, providing an added layer of protection.If you think you need assistance, push your help button immediately to initiate the help call.Pushing the help button generates the help call immediately.P.13 recommended usage push your autoalert help button any time you need help.If you fall and are able to, you should still push the autoalert button to send a help call right away.Per autoalert help button, instructions for use, p/n 0940718 rev.7 p.5 states: "in certain situations, the autoalert help button may not detect a fall.Some movements may not register as a fall and would not be detected.Examples include, but are not limited to: a gradual slide such as from a seated position; lowering oneself slowly to the ground (to brace the impact of a fall) , a fall from a height of less than 20 inches (0.5 meters).".

Event Description

The subscriber was unable to provide a date of the fall.She stated she had fallen forward and was unable to move.She stated she was on the floor for 6 hours.

• Brand Name: LIFELINE PERSONAL RESPONSE SYSTEM
• Type of Device: SYSTEM, COMMUNICATOR, POWERED
• Manufacturer (Section D): LIFELINE, INC.; 111 lawrence 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: 7141825
• MDR Text Key: 95600348
• Report Number: 1220762-2017-00002
• Device Sequence Number: 1
• Product Code: ILQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 12/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: FD100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/21/2017
• 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): Hospitalization
• Patient Age: 87 YR