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

Model Number 8374

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

Customer reported the alarm sounds intermittently when in use with the sensor.Issue was discovered during set-up, but date when found was not provided.No patient incident or injury was reported.

Manufacturer Narrative

Results: evaluation of the returned unit found that the unit does not sound intermittently on its own when in use with the sensor pad.The unit is silent when weight is applied to the senor pad, and the unit sounds when weight is removed from the sensor pad.However, the unit sounds on and off when the sensor cable is wiggled.The unit passed all other functional testing.The unit has been exposed to moisture and all pins inside the sensor receptacle are bent down.(b)(4).

• Brand Name: POSEY KEEPSAFE DELUXE
• Manufacturer (Section D): J. T. POSEY COMPANY; arcadia CA
• Manufacturer (Section G): J. T. POSEY COMPANY; 5635 peck rd.; arcadia CA 91006
• Manufacturer Contact: roxana koussa ; 5635 peck rd.; arcadia, CA 91006 ; 6264433143
• MDR Report Key: 4076391
• MDR Text Key: 4743113
• Report Number: 2020362-2014-00226
• 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: 05/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 06/06/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/23/2014
• Initial Date FDA Received: 06/23/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2012
• 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: SQUARE CHAIR SENSOR PAD 8308, LOT # UNK