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

Model Number 8345

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

Customer reported the alarm is not functioning properly however, the customer did not provide anymore information on what the specific issue was with the alarm.The issue was discovered during set up prior to putting into use with a patient.Customer did not provide the date when found.

Manufacturer Narrative

Results: evaluation of the returned alarm found that when the alarm is set on the sensor pad mode and a sensor is plugged into the alarm, when weight is removed from the sensor, the alarm does not sound.The nurse call led light does not come on when tested.There are two pins inside the sensor receptacle that are crossed over each other.(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 ; 5635 peck rd.; arcadia, CA 91006 ; 6264433143
• MDR Report Key: 4076542
• MDR Text Key: 20859212
• Report Number: 2020362-2014-00272
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2014
• 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
• Date Returned to Manufacturer: 08/06/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/07/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2013
• 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: OVER MATTRESS SENSOR PAD: MODEL 8307, LOT# UNK