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

Model Number 8345

Device Problem Improper Alarm (2951)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

Customer reported that the alarm does not send a signal to the nurse's station when the nurse call option is used.The issue was discovered during set up, but the date of the event is unk.No patient incident or injury was reported.

Manufacturer Narrative

Product was requested to be returned for evaluation, but has not been received.Note: this submission is based solely on the user facility reported issue.(b)(4).

• Brand Name: POSEY SITTER ELITE
• Type of Device: KMI
• Manufacturer (Section D): J. T. POSEY CO.; arcadia CA
• Manufacturer (Section G): J. T. POSEY CO.; 5635 peck rd.; arcadia CA 91006
• Manufacturer Contact: mary segura ; 5635 peck rd.; arcadia, CA 91006 ; 6264433143
• MDR Report Key: 4202407
• MDR Text Key: 17589361
• Report Number: 2020362-2014-00315
• 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: 08/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2014
• 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: 08/21/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/01/2013
• 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: NURSE CALL CABLE: MODEL: 8282, LOT#: UNK