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

Model Number 8374

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

Customer reported that when the alarm is selected to voice only or voice and tone, the voice message does not play.The batteries have been replaced with new ones.The date when the issue was discovered is unknown.No patient incident or injury reported.

Manufacturer Narrative

Evaluation of the returned product confirmed the reported issue.The voice message does not play when the unit is set to voice only or voice and tone; instead, a clicking sound is heard.The tone mode does play as it should.The nurse call light does not come on at the nurse call test fixture.The rj-11 pins have been pushed down into the receptacle.(b)(4).

• Brand Name: POSEY KEEPSAFE DELUXE
• 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: 3806828
• MDR Text Key: 4523111
• Report Number: 2020362-2014-00093
• 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: 02/18/2014

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: 8374
• Device Catalogue Number: 8374
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/28/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/18/2014
• Initial Date FDA Received: 03/14/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2010
• 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: BED SENSOR PAD: MODEL 8307, LOT# UNKNOWN