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

Model Number	FD100 (AAHB)
Health Effect - Clinical Codes	Death (1802); Fall (1848); Head Injury (1879)
Type of Reportable Event	Death
Additional Manufacturer Narrative
The device (aahb and communicator) was returned to the manufacturer on 8/29/2018.The aahb must be programmed to the communicator in order to signal the communicator and have it dial the call center.Upon examination it was discovered the aahb was not programmed to the communicator; therefore, no signals from the returned aahb would be able to signal the response center.Please note that, per the autoalert help button instructions for use, part number 0940718 rev.7 p.10, "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 -a fall from a height of less than 20 inches (0.5 meters)" p.13- if you fall and are able to, you should still push the autoalert help button to send a help call right away.".
Event or Problem Description
It was reported that the subscriber fell out of bed.She hit her head.The family reported the subscriber passed away as a result of her fall.

• Brand Name: LIFELINE PERSONAL RESPONSE SYSTEM
• Common Device Name: SYSTEM, COMMUNICATION, POWERED (ILQ)
• Manufacturer (Section D): LIFELINE SYSTEMS, INC.; 111 lawrence st.; framingham MA 01752
• MDR Report Key: 7911594
• Report Number: 1220762-2018-00003
• Device Sequence Number: 2305320
• Product Code: ILQ
• UDI-Device Identifier: 00884838081383
• UDI-Public: (01)00884838081383(11)171116
• Combination Product (Y/N): N
• PMA/510(K) Number: K914103
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: FD100 (AAHB)
• Device Catalogue Number: FD100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2018
• Initial Report FDA Received Date: 09/20/2018
• 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: Death
• Patient Age: 87 YR