PHILIPS LIFELINE MEDICAL ALERT NECKLACE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-06-16 for PHILIPS LIFELINE MEDICAL ALERT NECKLACE manufactured by Lifeline Systems, Inc..

Event Text Entries

[77948565] Caller is reporting on behalf of her mother who experienced a device malfunction on (b)(6) 2017 at 11:22am. She stated her mother suffered a stroke and needed assistance immediately. Allegedly, the connecting time for the medical alert necklace is 2-3 mins when the help button is activated. After waiting for 2 mins, reporter called 911 for assistance. She stated the philips lifeline had still not connected and it gave a message "help call in progress" and "connecting". Finally, they responded after 4 mins of waiting. She reports the issue with the device has been on going for about 3 months. User has been experiencing long connecting times. She initially thought the issue had to do with the landline and switched to wireless but the problem continued to occur. Reporter reached out to the franchise regarding the issue and wanted the line switched back to the landline but instead she felt lied to by the provider (b)(6). She reports they did not assist her she believes that she was rather abused, threatened and lied to. Reporter believes the device is dangerous due to the long connecting time when there is an emergency that needs immediate response.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5070486
• MDR Report Key: 6650229
• Date Received: 2017-06-16
• Date of Report: 2017-06-16
• Date of Event: 2017-06-09
• Date Added to Maude: 2017-06-19
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Details

• Brand Name: PHILIPS LIFELINE MEDICAL ALERT NECKLACE
• Generic Name: LIFELINE PERSONAL RESPONSE SYSTEM
• Product Code: ILQ
• Date Received: 2017-06-16
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: LIFELINE SYSTEMS, INC.

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Life Threatening	2017-06-16