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

Model Number FD100 (AAHB)

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Fall (1848); Head Injury (1879)

Event Type  Death  

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 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
• Type of Device: SYSTEM, COMMUNICATION, POWERED (ILQ)
• Manufacturer (Section D): LIFELINE SYSTEMS, INC.; 111 lawrence st.; framingham MA 01752
• Manufacturer (Section G): RESPIRONICS, INC.; 312 alvin drive; new kensington PA 15068
• Manufacturer Contact: ingrid sawvelle ; 111 lawrence st.; framingham, MA 01701 ; 5089881079
• MDR Report Key: 7911594
• MDR Text Key: 122134328
• Report Number: 1220762-2018-00003
• Device Sequence Number: 1
• Product Code: ILQ
• UDI-Device Identifier: 00884838081383
• UDI-Public: (01)00884838081383(11)171116
• Combination Product (y/n): N
• PMA/PMN Number: K914103
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2018
• Is this an Adverse Event Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 08/29/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/16/2018
• 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: 87 YR