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

Model Number 8374

Device Problem False Alarm (1013)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

Customer reported the alarm sound continuously which was discovered during set up.Customer did not provide the date of event.No pt incident of injury was reported.

Manufacturer Narrative

Eval - results: eval of the returned alarm did not confirm the reported issue.However, the nurse call light toggles on and off when the nurse call cable is wiggled while plugged into the receptacle on the alarm.The nurse call receptacle is loose on the alarm.The alarm passes all other functional tests.Damage found may contribute to the issue seen.This alarm has been in service for over two years.Note: all complaints are trended and reviewed by management on a monthly basis.As part of this monthly review, any excursion above the control limits for this failure mode will be assessed, documented and acted upon as warranted.No corrective or preventative actions are necessary at this time.(b)(4).

• Brand Name: KEEPSAFE DLUXE
• 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, product surveill ; 5635 peck rd.; arcadia, CA 91006 ; 6264433143
• MDR Report Key: 4317435
• MDR Text Key: 5212958
• Report Number: 2020362-2014-00362
• 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: Unknown
• Type of Report: Initial
• Report Date: 11/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2014
• 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: 10/29/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/03/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2012
• 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-THE-MATRESS SENSOR PAD MODEL:8307, LOT# UNK