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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: J. T. POSEY COMPANY SITTER ELITE
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J. T. POSEY COMPANY SITTER ELITE Back to Search Results
Model Number 8345
Device Problems Device Alarm System (1012); Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Event Description
Customer reported the nurse call outlet to the alarm is broken.Customer reported issue was discovered during set-up but a date was not provided.No patient incident or injury was reported.
 
Manufacturer Narrative
Results: evaluation of the returned unit confirmed that the nurse call receptacle is broken and has a loose connection.The nurse call led functions when tested, but if the nurse call cable is moved, the nurse call will turn on and off.
 
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Brand Name
SITTER ELITE
Manufacturer (Section D)
J. T. POSEY COMPANY
arcadia CA
Manufacturer (Section G)
J. T. POSEY COMPANY
5635 peck road
arcadia CA 91006
Manufacturer Contact
roxana koussa
5635 peck road
arcadia, CA 91006
6264433143
MDR Report Key3886459
MDR Text Key4648933
Report Number2020362-2014-00133
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 01/31/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/10/2014
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 Manufacturer02/28/2014
Is the Reporter a Health Professional? No
Date Manufacturer Received03/13/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/01/2012
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
CHAIR SENSOR: PART # 8309, LOT # UNK
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