MAUDE Adverse Event Report: PHILIPS LIFELINE PHILIPS LIFELINE GOSAFE WIRELESS COMMUNICATOR

Model Number 7000C

Device Problems Labelling, Instructions for Use or Training Problem (1318); Device Difficult to Setup or Prepare (1487)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/26/2016

Event Type  malfunction  

Event Description

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.

• Brand Name: PHILIPS LIFELINE GOSAFE WIRELESS COMMUNICATOR
• Type of Device: PHILIPS LIFELINE GOSAFE WIRELESS COMMUNICATOR
• Manufacturer (Section D): PHILIPS LIFELINE
• MDR Report Key: 5694336
• MDR Text Key: 46475734
• Report Number: MW5062593
• Device Sequence Number: 1
• Product Code: ILQ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: No Information
• Type of Report: Initial
• Report Date: 05/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 7000C
• Was Device Available for Evaluation?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 70 YR
• Patient Weight: 50