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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: J. T. POSEY CO. KEEPSAFE DELUXE
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J. T. POSEY CO. KEEPSAFE DELUXE Back to Search Results
Model Number 8374
Device Problem Mechanical Problem (1384)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Event Description
Customer reported the on/off switch is difficult to use; the switch sometimes gets stuck in the on or off position.Customer did not provide a date when the issue was discovered.No pt incident or injury was reported.
 
Manufacturer Narrative
Eval: results - eval of the returned unit confirmed the on/off switch is difficult to use.The pre-recorded voice message does not play - only clicking sounds can be heard when weight is removed from the sensor pad.The unit's tone plays properly and all other functional tests passed.(b)(4).
 
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Brand Name
KEEPSAFE DELUXE
Manufacturer (Section D)
J. T. POSEY CO.
arcadia CA
Manufacturer (Section G)
J. T. POSEY CO.
5635 peck rd.
arcadia CA 91006
Manufacturer Contact
roxana koussa
5635 peck rd.
arcadia, CA 91006
6264433143
MDR Report Key4451372
MDR Text Key21726288
Report Number2020362-2015-00020
Device Sequence Number1
Product Code KMI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 01/12/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/23/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number8374
Device Catalogue Number8374
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer01/05/2015
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/12/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/01/2012
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Treatment
NURSE CALL CABLE, PART #: 8282
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