FDA.reportPublic FDA data

MAUDE MDR 3534177

MDR report key
3534177
Report number
1220762-2013-00002
Event key
0
Event type
3
Date of event
2013-11-15
Date received
2013-12-18
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
INGRID SAWVELLE
Address
111 LAWRENCE ST. FRAMINGHAM MA 01702 US
Phone
508-508-5089
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1LIFELINE PERSONAL RESPONSE SYSTEMSYSTEM, COMMUNICATION, POWEREDILQFD100Y Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12013-12-1801. H

Event Narratives#

N

Patient 1

THE SUBSCRIBER'S INJURY WAS A RESULT OF A FALL DOWN A STAIR WELL. THE INVOLVED EQUIPMENT (MODEL FD100) WAS NOT THE CAUSE OF THE FALL. THE FD100 IS NOT LABELED AS A LIFE SUSTAINING DEVICE. THE INVOLVED EQUIPMENT WAS RETURNED FOR EVAL AND IT WAS DETERMINED THAT THE BATTERY ON THE SUBSCRIBER'S FD100 WAS DEPLETED. THE FD100 HAS A LOW BATTERY DETECTION ALGORITHM WHICH IS A TIME-BASED SERIES OF INTERNAL VOLTAGE CHECKS WHICH TAKES 24 HRS TO COMPLETE. IN THIS CASE, THE BATTERY DEPLETION WAS TOO RAPID WHICH RESULTED IN DEPLETION BEFORE THE FD100 ALGORITHM COULD COMPLETE ITS INTERNAL VOLTAGE CHECKS. CONSEQUENTLY, NO LOW BATTERY SIGNAL WAS SENT TO THE RESPONSE CENTER TO TRIGGER THE FD100 REPLACEMENT PROCESS. SUBSCRIBERS ARE ALSO AUTOMATICALLY REMINDED TO TEST THEIR EQUIPMENT EVERY MONTH TO DETECT ANY ISSUES.

D

Patient 1

SUBSCRIBER HAD FALLEN IN THE STAIR WELL AND HIS AUTOALERT HELP BUTTON DID NOT SIGNAL. HE WAS FOUND THE NEXT DAY BY A HOME SUPPORT WORKER. IT WAS INDICATED THAT THE SUBSCRIBER HAD A BROKEN HIP AND WAS HOSPITALIZED.