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

Model Number	FD100
Health Effect - Clinical Codes	Stroke/CVA (1770); Fall (1848); Head Injury (1879)
Date of Event	10/02/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As reported to fda in 1220762-11-15-2017-001-r, the involved button was an affected device.The button did not have the appropriate fall parameters.It is unclear from the information received by the manufacturer if the button may have contributed to any injury the subscriber sustained.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)." the involved button was still able to be depressed to summon help.
Event or Problem Description
The subscriber fell and hit her head.It is unclear if she hit her head and then had a stroke or if the stroke caused her to fall and she hit her head in the process.This happened in her bedroom the night of the (b)(6) or the morning of the (b)(6).

• Brand Name: LIFELINE PERSONAL RESPONSE SYSTEM
• Common Device Name: SYSTEM, COMMUNICATION, POWERED
• Manufacturer (Section D): LIFELINE SYSTEMS, INC.; 111 lawrence st.; framingham MA 01702
• MDR Report Key: 7141811
• Report Number: 1220762-2017-00001
• Device Sequence Number: 1238046
• Product Code: ILQ
• UDI-Device Identifier: 00884838084957
• UDI-Public: (01)00884838084957(11)160208(96)170814
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 12/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: FD100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2017
• Initial Report FDA Received Date: 12/22/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 86 YR