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

Model Number 8361

Device Problems Device Alarm System (1012); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

Customer reported there is a delay for the alarm to sound when the magnet is disconnected from the alarm.Batteries have been replaced with a new supply.No visible damage to the outside of the alarm.The date when the issue was discovered is unk.No pt incident or injury reported.

Manufacturer Narrative

Results: eval of the returned product did not confirm the reported issue.Unit powers up and alarm sounds immediately after the magnet is removed from the magnet plate and there is no delay, which is normal.There is a 4 second delay before the alarm sounds while using the sensor pad, because of the delay switch being set to 4 secs.The delay function only works while a sensor pad is connected.The unit passed all functional tests, however, the battery springs are bent.(b)(4).

• Brand Name: SITTER SELECT
• Manufacturer (Section D): J. T. POSEY COMPANY; 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: 3909880
• MDR Text Key: 4669214
• Report Number: 2020362-2014-00066
• 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: 01/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8361
• Device Catalogue Number: 8361
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/07/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/13/2014
• Initial Date FDA Received: 02/26/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2004
• 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: MODEL 8361M, LOT #NA