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  

Manufacturer Narrative

Eval results: customer reported that the second product in use with this alarm is the pull magnet.When the pull magnet is removed from the alarm, the alarm does not sound continuously.However, when the nurse call cable is plugged into the nurse call receptacle and the cable is moved, the nurse call light toggles on and off at the nurse's station.When the sensor is attached to the alarm, the alarm sounds continuously with weight on or off the sensor pad which is due to all of the pins inside the sensor receptacle are bent down.The alarm has evidence of being exposed to moisture and there is battery leakage on the flat battery contact and battery springs.The damages found on the alarm unit could contribute to the issues found.The alarm has been in service for over two years.Mfr ref file # (b)(4).

Event Description

The customer reported the alarm does not silence when the hold button is selected.Customer reported this was discovered during set up, however, did not know the date of event.No pt incident or injury was reported.

• 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: 4339642
• MDR Text Key: 58536962
• Report Number: 2020362-2014-00389
• 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 faci
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 11/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2014
• 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: 11/20/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/21/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1