MAUDE Adverse Event Report: J. T. POSEY CO. KEEP SAFE DELUXE

Model Number 8374

Device Problems Failure to Power Up (1476); 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 will not power on.Batteries have been replaced with a new supply.Customer did not provide a date when issue was discovered.No pt incident or injury was reported.

Manufacturer Narrative

Results: evaluation of the returned unit did not confirm the reported issue of no power.The unit has power and functions, however the factory message does not play and a clicking noise sounds in its place.The tone plays as it should.(b)(4).

• Brand Name: KEEP SAFE 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: roxana koussa ; 5635 peck rd.; arcadia, CA 91006 ; 6264433143
• MDR Report Key: 3886492
• MDR Text Key: 4675327
• Report Number: 2020362-2014-00135
• 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: 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: 02/26/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/10/2014
• Initial Date FDA Received: 04/10/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2013
• 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: OVER MATTRESS SENSOR PART # 8307, LOT # UNK