KEEPSAFE ESSENTIAL 8373

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2018-08-03 for KEEPSAFE ESSENTIAL 8373 manufactured by Posey Products Llc.

Event Text Entries

[116066082] Visual findings revealed that the device battery compartment has signs of previous battery corrosion such as white powder residue on battery flat contacts, battery springs, compartment side wall, the back of the battery door, and red ribbon. Evaluation found when the unit is set to voice only and voice & tone modes, the pre-recorded voice message will not play? Only clicking sounds can be heard when weight is off the sensor pad due to a defective voice chip. Due to the age of the device it is likely that wear and tear may have contributed to the malfunction. At this time, there is no evidence that a manufacturing non-conformity contributed to the reported complaint and the instructions for use were reviewed and determined to provide adequate instructions and warning for the safe and effective use of the device. Therefore, no corrective or preventative actions are necessary. All complaints are trended and reviewed by management on a monthly basis. As part of this monthly review, any excursion above the control limits for this failure mode will be assessed, documented and acted upon as warrant. Manufacturer reference file#: (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[116066083] Customer did not specify the nature of the complaint. Evaluation found the alarm will not play the prerecorded message. The date the issue was discovered is unknown and no patient incident or injury was reported.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2020362-2018-00100
MDR Report Key7749432
Report SourceHEALTH PROFESSIONAL,USER FACI
Date Received2018-08-03
Date of Report2018-06-11
Date Mfgr Received2018-07-11
Device Manufacturer Date2012-08-06
Date Added to Maude2018-08-03
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactWILLIAM HINCY
Manufacturer Street5635 PECK ROAD
Manufacturer CityARCADIA CA 91006
Manufacturer CountryUS
Manufacturer Postal91006
Manufacturer Phone6264433143
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameKEEPSAFE ESSENTIAL
Generic NameFALL PREVENTION ALARM/SENSOR ATTACHED ONLY
Product CodePJP
Date Received2018-08-03
Returned To Mfg2018-07-09
Model Number8373
Catalog Number8373
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerPOSEY PRODUCTS LLC
Manufacturer Address5635 PECK ROAD ARCADIA 91006 US 91006


Patients

Patient NumberTreatmentOutcomeDate
10 2018-08-03

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