MAUDE Adverse Event Report: J. T. POSEY CO. SITTER ELITE

Model Number 8345

Device Problem False Alarm (1013)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

Customer reported the alarm is not in working condition, but was unable to provide any more information on the issue.Customer could not provide the date of event.No patient incident or injury was reported.

Manufacturer Narrative

Results: evaluation of the returned alarm found a note on the device with the comment "nurse call constant".The unit does not continuously send signal to activate the nurse call light at the test fixture.However, if the nurse call cable is moved the led light at the nurse call test fixture toggles on and off.The nurse call receptacle is loose.Alarm has evidence of being exposed to moisture.Damages to the alarm contribute to the issues found.(b)(4).

• 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: pam wampler ; 5635 peck rd.; arcadia, CA 91006 ; 6264433143
• MDR Report Key: 4139628
• MDR Text Key: 4948277
• Report Number: 2020362-2014-00317
• Device Sequence Number: 1
• Product Code: KMI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 8345
• Device Catalogue Number: 8345
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/11/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/12/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1