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

Model Number 8345

Device Problem Improper Alarm (2951)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

Customer reported when the alarm is in use with the nurse call cable, the nurse's station does not sound when weight is lifted from the sensor pad.The issue was discovered during set up.No patient incident or injury was reported.

Manufacturer Narrative

Product was requested to be returned for evaluation and has not been received.Note: this report is submitted based on the customers initial reported issue.(b)(4).

• Brand Name: POSEY SITTER ELITE
• Manufacturer (Section D): J. T. POSEY COMPANY; arcadia CA
• Manufacturer (Section G): J. T. POSEY COMPANY; 5635 peck road; arcadia CA 91006
• Manufacturer Contact: mary segura ; 5635 peck road; arcadia, CA 91006 ; 6464433143
• MDR Report Key: 4102213
• MDR Text Key: 15120316
• Report Number: 2020362-2014-00313
• 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: 08/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2014
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/13/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/01/2012
• 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
• Treatment: NURSE CALL CABLE, MODEL 8282, LOT # UNKNOWN.