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

Model Number 8374

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

The customer reported the alarm is not functioning properly, but could not provide any more information on the issue with the alarm.The customer 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 unit has power, but does not sound when the sensor pad is unplugged from the alarm.The alarm does not sound when the sensor pad is plugged in and weight is removed from the sensor pad.The unit's speaker was tested and it is above the normal range, which caused the alarm not to sound.There are scuff marks and deep scrapes on the green over mold on the alarm case.No other physical damage is observed.(b)(4).

• Brand Name: 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: pam wampler ; 5635 peck rd.; arcadia, CA 91006 ; 6264433143
• MDR Report Key: 4109145
• MDR Text Key: 18288795
• Report Number: 2020362-2014-00295
• 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: 08/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2014
• 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: 08/25/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/27/2014
• 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: DISPOSABLE SENSOR: MODEL 8283, LOT #UNK