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

Model Number 8345

Device Problems Device Alarm System (1012); Battery Problem (2885); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

Customer reported that they discovered during set up that the alarm has power, but does not sound when the magnet pull cord is detached.The customer reported the batteries have been replaced with a new supply and no visible damage was reported.Customer could not provide a date when found.No patient incident or injury reported.

Manufacturer Narrative

Results: evaluation of the returned product confirmed the reported issue, unit does not sound when the pull magnet is detached or when there is no sensor cable plugged into the wall.No physical damages found on 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, administrator ; 5635 peck rd.; arcadia, CA 91006 ; 6264433143
• MDR Report Key: 3972920
• MDR Text Key: 4750653
• Report Number: 2020362-2014-00164
• 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: 03/26/2014

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 Number: 8345
• Device Catalogue Number: 8345
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/18/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/26/2014
• Initial Date FDA Received: 04/28/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2013
• 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 8345M