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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: J. T. POSEY CO. SITER ELITE
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J. T. POSEY CO. SITER ELITE Back to Search Results
Model Number 8345
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Event Description
The customer reported there appears to be visible damage to the nurse call port where the nurse call cable is inserted.The customer did not provide the date when found.No patient incident or injury was reported.
 
Manufacturer Narrative
Results: evaluation of the returned product found the nurse call receptacle is damaged, does not secure the nurse call cable and when the cable is wiggled or moved the nurse call light goes on and off.Unit passes all other functional tests.The alarms case is cracked and there is a rattling sound coming from inside the unit.One of the battery springs is bent.(b)(4).
 
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Brand Name
SITER 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
pam wampler, administrator
5635 peck rd.
arcadia, CA 91006
6264433143
MDR Report Key3818678
MDR Text Key4451092
Report Number2020362-2014-00140
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 Other
Type of Report Initial
Report Date 03/10/2014
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 Manufacturer03/26/2014
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 04/02/2014
Initial Date FDA Received04/08/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/01/2011
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Treatment
NURSE CALL CABLE: PN 8282
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