MAUDE Adverse Event Report: J. T. POSEY CO. POSEY KEEPSAFE ESSENTIAL

Model Number 8373

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

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

Customer reported the alarm does not sound when the magnet pull cord is detached from the alarm.Customer reported the alarm sounds when the tone button is pressed.Batteries have been replaced with a new supply.Issue was discovered during set-up, but date when found was not provided.No patient incident or injury was provided.No visible damage reported.

Manufacturer Narrative

Results: evaluation of the returned unit confirmed the reported issue.The unit has power (green led is blinking), but does not sound when there is no magnet attached.When the tone selection is pressed five different tones can be heard.There are no physical damages to the alarm.(b)(4).

• Brand Name: POSEY KEEPSAFE ESSENTIAL
• Manufacturer (Section D): J. T. POSEY CO.; arcadia CA
• Manufacturer (Section G): J. T. POSEY CO.; 5635 peck rd.; arcadia CA 91006
• Manufacturer Contact: roxana koussa ; 5635 peck rd.; arcadia, CA 91006 ; 6264433143
• MDR Report Key: 4074184
• MDR Text Key: 4852781
• Report Number: 2020362-2014-00222
• 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: Unknown
• Type of Report: Initial
• Report Date: 05/20/2014

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: 8373
• Device Catalogue Number: 8373
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/13/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/20/2014
• Initial Date FDA Received: 06/23/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2013
• 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: KEEPSAFE ESSENTIAL MAGNET 8373M, LOT # UNK