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

Model Number 8374

Device Problem Device Damaged Prior to Use (2284)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

Customer reported the on/off buttons are missing from the alarm which was discovered during set up.Customer did not provide a date of event.No pt incident or injury was reported.

Manufacturer Narrative

Eval codes: eval of the alarm confirmed the reported issue; the power switch lever broke off; as a result, the power switch cannot be slid to either on or off state.However, when batteries are inserted the alarm powered on.The pre-recorded voice message does not play, only clicking sounds can be heard when weight is removed from the sensor pad due to a non-functioning voice chip.The unit's tone plays properly.The unit passes all other functional testing.There is corrosion on all of the pins inside the sensor receptacle.

• Brand Name: POSEY 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, product surveill ; 5635 peck rd.; arcadia, CA 91006 ; 6264433143
• MDR Report Key: 4397513
• MDR Text Key: 16852208
• Report Number: 2020362-2014-00433
• 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: 12/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2015
• 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: 12/11/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/18/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2013
• 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