FDA.reportPublic FDA data

MAUDE MDR 5694336

MDR report key
5694336
Report number
MW5062593
Event key
0
Event type
3
Date of event
2016-05-26
Date received
2016-05-27
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1PHILIPS LIFELINE GOSAFE WIRELESS COMMUNICATORPHILIPS LIFELINE GOSAFE WIRELESS COMMUNICATORPHILIPS LIFELINEILQ7000C* Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12016-05-2701. O

Event Narratives#

D

Patient 1

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.