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

Model Number 8374

Device Problem False Alarm (1013)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

Customer reported the alarm is still alarming even thought he hold/suspend button has been pressed.The alarm was tested with a test strip.Customer did not know when the issue was discovered or the date of event.No patient incident or injury was reported.

Manufacturer Narrative

Results: evaluation of the alarm did not confirm the reported issue; the hold/suspend modes work as intended.However, the pre-recorded voice message does not play - only a signal click ca be hard due to a faulty voice chip.There is evidence of exposure to moisture to the alarm unit.The red ribbon that is attached to the outside of the battery compartment is missing.There are scrapes on the green over mold of the alarm case.The manufacture date indicates the unit has been in service for over three years.(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: 4148373
• MDR Text Key: 4785003
• Report Number: 2020362-2014-00326
• 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: 09/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2014
• 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: 09/05/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/10/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2011
• 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
• Treatment: OVER-THE-MATTRESS SENSOR PAD 8307, LOT #UNK