MAUDE Adverse Event Report: PHILIPS LIFELINE LIFELINE PERSONAL RESPONSE SYSTEM; SYSTEM, COMMUNICATION, POWERED

Model Number	FD100
Health Effect - Clinical Codes	Fall (1848); Bone Fracture(s) (1870); Hemorrhage/Blood Loss/Bleeding (1888); Loss of consciousness (2418)
Date of Event	03/13/2018
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 0940817 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.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 help button to send a help call right away.Per autoalert help button, instructions for use, p/n 0940718 rev.5 page states: "in certain situations, the autoalert may not detect a fall.Some movements may not register as a fall and would not be detected." the involved button was still able to be depressed to summon help.
Event or Problem Description
The subscriber had a fall down several stairs.She was unconscious.She was bleeding from the fall and had broken several bones.

• Brand Name: LIFELINE PERSONAL RESPONSE SYSTEM
• Common Device Name: SYSTEM, COMMUNICATION, POWERED
• Manufacturer (Section D): PHILIPS LIFELINE; 111 lawrence st; framingham MA 01702 8156
• MDR Report Key: 7429876
• Report Number: 1220762-2018-00001
• Device Sequence Number: 13947290
• Product Code: ILQ
• UDI-Device Identifier: 00884838084957
• UDI-Public: (01)00884838084957(11)141209(96)170925
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 03/19/2018

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: Patient Family Member or Friend
• Device Model Number: FD100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/19/2018
• Initial Report FDA Received Date: 04/13/2018
• 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: Hospitalization