FDA.reportPublic FDA data

MAUDE MDR 3697942

MDR report key
3697942
Report number
3008101184-2014-00008
Event key
0
Event type
3
Date of event
2014-02-19
Date received
2014-03-25
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
0
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
MR. GARY BECKER
Address
3701 FAU BLVD SUITE 300 BOCA RATON 33431 US
Phone
561-561-5613
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1MOBILEHELP - DUO SYSTEMPERSONAL EMERGENCY RESPONSE SYSTEMINTEGRITY TRACKING, LLC/ DBA MOBILEHELPILQIGB-01Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12014-03-2501. O

Event Narratives#

D

Patient 1

ON (B)(6) 2014 AROUND 7:50AM SUBSCRIBER FELL AND NEEDED HELP INSIDE HER HOME. SUBSCRIBER PRESSED HER PENDANT MULTIPLE TIMES BUT DID NOT GET A RESPONSE. SHE ALSO PRESSED HER MOBILE DEVICE THAT WAS IN HER PURSE AND DID NOT GET A RESPONSE. SHE WAS ON FLOOR FOR ABOUT 1.5 HOURS UNTIL (B)(6) (RELATIVE) HAD SOMEONE GO CHECK ON HER BECAUSE SHE WASN'T ANSWERING HER PHONE. SUBSCRIBER IS IN REHAB NOW AFTER HAVING SOME KIND OF OUTPATIENT SURGERY PERFORMED. SUBSCRIBER HAS A COMPRESSED STRESS FRACTURE.

N

Patient 1

BASE STATION LOST TRAINING TO THE PENDANT. THIS RESULTED IN THE BASE STATION FAILING TO ACTIVATE WHEN THE PENDANT BUTTON WAS PUSHED. THE MOBILE DEVICE SHOWED A LOW BATTERY SIGNAL ON (B)(6) 2014, INDICATING A STRONG POSSIBILITY THAT IT LOST POWER, AND THEREFORE, THE MOBILE DEVICE BUTTON PRESS RESULTED IN THE UNIT NOT ACTIVATING. THE DEVICES WERE SWAPPED OUT WITH THE LATEST VERSION OF THE BASE STATION (CELLULAR) AND THE MOBILE DEVICE. THE SYSTEM IS NOW FUNCTIONAL.