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

Model Number 8361

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

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

The customer reported that the alarm powers on, but is sounding inconsistently.This issue was discovered during set up, but the date of the event is unknown.No patient injury was reported.

Manufacturer Narrative

Results - evaluation of the returned product confirmed the reported issue and revealed the unit initially powers on with batteries and passed sensor testing.However, when the unit is tested for voice only mode, the unit lost power on its own.Unit was retested for power using batteries, but unit did not power on, therefore, unit is non-functional.Additional invasive tests found the unit's output voltage is below range.Visual findings observed that unit has a crack on the lower right corner and scrapes on the front enclosure.The warning label is missing, therefore could not determine the manufactured site.Also, the sensor receptacle is elevated from the pcba.(b)(4).

• Brand Name: POSEY SITTER SELECT
• 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: 4137675
• MDR Text Key: 21878671
• Report Number: 2020362-2014-00316
• 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: 08/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2014
• 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: 09/11/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/28/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2011
• 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: BAD SENSOR PAD: MODEL 8307, LOT #UNK