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

Model Number 8374

Device Problems Device Operates Differently Than Expected (2913); Device Operational Issue (2914)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

Customer reported the alarm is not in working condition but could not provide any specific information.Customer reported the issue was discovered during set up, but could not provide the date of the event.No patient incident or injury was reported.

Manufacturer Narrative

Results - evaluation of the returned alarm found the nurse call receptacle is loose.When the nurse call cable is inside of the receptacle and wiggled the nurse call light toggles on and off.The unit passed all other functional testing.The device has been in service for over three years and the damage to the nurse call receptacle could contribute to these findings.(b)(4).

• Brand Name: POSEY KEEPSAFE DELUX
• 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: 4240080
• MDR Text Key: 5014764
• Report Number: 2020362-2014-00348
• Device Sequence Number: 1
• Product Code: KMI
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 10/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8374
• Device Catalogue Number: 8374
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/08/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/10/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2011
• 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