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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: J. T. POSEY CO. SITTER ELITE
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J. T. POSEY CO. SITTER ELITE Back to Search Results
Model Number 8345
Device Problem Defective Alarm (1014)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Event Description
Customer reported the alarm sounds continuously when weight is applied to sensor.Batteries have been replaced with a new supply.Customer did not provide a date when issue was discovered.No pt incident or injury was reported.
 
Manufacturer Narrative
Evaluation found that the factory message plays once then stops; normally the tone would sound or the voice message would play continually.Unit passes all other functional tests.(b)(4).
 
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Brand Name
SITTER ELITE
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 Key3915483
MDR Text Key4488568
Report Number2020362-2014-00061
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 User Facility
Reporter Occupation Unknown
Type of Report Initial
Report Date 01/14/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number8345
Device Catalogue Number8345
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer01/22/2014
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 01/31/2014
Initial Date FDA Received02/25/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/01/2012
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
OVER MATTRESS SENSOR: PART # 8307, LOT #UNK
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