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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 False Alarm (1013)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Event Description
Customer reported that when the alarm is set to voice and tone, the voice portion only sounds.Customer reported it was discovered during set up.Customer did not provide the date of event.No pt incident or injury was reported.
 
Manufacturer Narrative
Results: eval of the returned alarm found the unit only plays the tone mode once when the unit set to tone mode.The unit does not play the pre-recorded message when the unit is set to voice and tone mode.There are cuts on the green over mold covers.The alarm has been in svc for over 4 yrs.(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
pam wampler
5635 peck rd.
arcadia, CA 91006
6264433143
MDR Report Key4451371
MDR Text Key15127732
Report Number2020362-2015-00012
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 12/23/2014
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 Lay User/Patient
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 Received12/23/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/01/2010
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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