PHILIPS LIFELINE GOSAFE WIRELESS COMMUNICATOR 7000C

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-05-27 for PHILIPS LIFELINE GOSAFE WIRELESS COMMUNICATOR 7000C manufactured by Philips Lifeline.

Event Text Entries

[46475734] Philips lifelink gosafe medical alert system. Communicator does not perform as documented (quick setup guide, p/n 0940833, rev. 01) during setup. Setup guide reads "turn on the home communicator using the switch on the back. " "press the flashing, orange message button when you are ready to continue. " "plug the power cord into an easily accessible outlet. Choose a power outlet that can not be turned off by a wall switch. Press the flashing, orange message button when you are ready to continue. " problem: flashing orange message button does not come on after turning communicator on but before plugging in. When communicator is plugged in the button does flash. The voice guidance that launches when the flashing button is pressed (after the communicator is plugged in) says "now plug me in. " confusing to elderly customers because machine does not perform as the setup guide says it should. Call to technical support. Agent says that the communicator must be plugged in before the message button light will flash. Told him that this is not what the instructions say. He replies that instructions are wrong.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5062593
• MDR Report Key: 5694336
• Date Received: 2016-05-27
• Date of Report: 2016-05-27
• Date of Event: 2016-05-26
• Date Added to Maude: 2016-06-02
• 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 GOSAFE WIRELESS COMMUNICATOR
• Generic Name: PHILIPS LIFELINE GOSAFE WIRELESS COMMUNICATOR
• Product Code: ILQ
• Date Received: 2016-05-27
• Model Number: 7000C
• Device Availability: Y
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: PHILIPS LIFELINE

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2016-05-27