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

Model Number 8345

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

Customer reported the alarm is not functioning properly, customer has no further information.No patient incident or injury was reported.

Manufacturer Narrative

Results: evaluation of the returned alarm found it does not power on with batteries, but does power on with the 9v adapter power supply.The nurse call receptacle's housing is loose, the internal mechanism inside the nurse call receptacle is no longer intact and when the cable is inserted, there is not a secure fit.The unit does not send a signal to activate the nurse call light at the test fixture when weight is off the sensor pad.When the cable is moved while inside the receptacle, the nurse call light at the test fixture toggles on and off.The unit's battery connectors have battery acid corrosion on them and once removed the alarm powers on with batteries.(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: pam wampler ; 5635 peck road; arcadia, CA 91006 ; 6264433143
• MDR Report Key: 4321666
• MDR Text Key: 5207869
• Report Number: 2020362-2014-00380
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2014
• 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: 11/10/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/11/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2012
• 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: MAGNET 8345M