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

Model Number 8374

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

Patient Problem Fall (1848)

Event Type  malfunction  

Event Description

Customer reported when the alarm was in use with a pt, the alarm sounded when weight was removed from the pad.However, the pt fell but no pt injury occurred.Customer did not provide the date of event or any pt information.

Manufacturer Narrative

Results: evaluation of the alarm found when the unit was received it was set on voice and tone mode.The tone plays while weight is off the sensor pad.However, the pre-recorded voice message does not play - only a clicking sound is heard in place of the voice message due to a damaged voice chip.There is battery leakage/corrosion on the battery contacts and springs and the product has been in service for over two years.(b)(4).

• Brand Name: POSEY KEEPSAFE DELUXE
• Manufacturer (Section D): J.T. POSEY COMPANY; 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: 4450112
• MDR Text Key: 20063696
• Report Number: 2020362-2015-00010
• 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: 12/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2015
• 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: 01/06/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/23/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2012
• 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 MATTRESS SENSOR PAD, MODEL: 8307, LOT # UNK