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

Model Number 8345

Device Problem False Alarm (1013)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

Customer reported that alarm sounds when the magnet pull cord is attached to the alarm.This was discovered during set up.Customer could not provide the date of event.No pt incident or injury was reported.

Manufacturer Narrative

Results: evaluation of the returned alarm did not confirm the reported issue; the unit does not sound continuously when a magnet is in use.However, the nurse call light goes on and off when the nurse call cable is moved while inside the nurse call receptacle.The nurse call receptacle is loose, but the cable has a tight fit when inserted in the receptacle.The unit passed all other functional testing.There are scuff marks on the green over mold covers, no other physical damage was observed to the unit.(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: 4450113
• MDR Text Key: 21244727
• Report Number: 2020362-2015-00009
• 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: User Facility
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 12/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8345
• Device Catalogue Number: 8345
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/20/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/29/2014
• 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
• Treatment: MAGNET PN 8345M