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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: J. T. POSEY CO. POSEY KEEPSAFE DELUXE
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J. T. POSEY CO. POSEY KEEPSAFE DELUXE Back to Search Results
Model Number 8374
Device Problem Device Damaged Prior to Use (2284)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Event Description
Customer reported that when the alarm is set to voice and tone mode, the pre-recorded message is not heard.The reported issue was discovered during set up, but the date of the event is unknown.No patient incident or injury was reported.
 
Manufacturer Narrative
Results: evaluation of the returned product confirmed the reported issue.The unit's voice message does not play when weight is removed from the sensor pad, only a clicking sound is heard.The unit's tone plays properly.There is battery leakage and corrosion on the battery flat contacts.(b)(4).
 
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Brand Name
POSEY 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
mary segura
5635 peck rd.
arcadia, CA 91006
6264433143
MDR Report Key4121591
MDR Text Key4919181
Report Number2020362-2014-00251
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 06/27/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/29/2014
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? Device Returned to Manufacturer
Date Returned to Manufacturer07/14/2014
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/27/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/01/2011
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
CHAIR SENSOR, SQUARE, 6-MONTH, MODEL 8308,; LOT # UNKNOWN.
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