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

Model Number 8345

Device Problem Low Audible Alarm (1016)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

Customer reported the volume on the alarm fades.New batteries have been installed.Issue was discovered during set-up but date is not known.No patient incident or injury was reported.

Manufacturer Narrative

Evaluation - results reported issue is confirmed.Evaluation found the alarm's sound dies off when alarming in low and medium volumes.The alarm passes all functional tests when alarming in high volume.The alarm has cracks on the dust covers that protect the internal components.The physical damages observed to the unit may have contributed to the malfunction.(b)(4).

• Brand Name: SITTER ELITE
• Type of Device: KMI
• Manufacturer (Section D): J. T. POSEY COMPANY; arcadia CA
• Manufacturer (Section G): J. T. POSEY COMPANY; 5635 peck road; arcadia CA 91006
• Manufacturer Contact: roxana koussa ; 5635 peck road; arcadia, CA 91006 ; 6264433143
• MDR Report Key: 4374464
• MDR Text Key: 5235412
• Report Number: 2020362-2014-00404
• 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: 12/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/24/2014
• 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: 10/29/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/05/2014
• 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: 8345M MAGNET