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

Model Number 8374

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/12/2014

Event Type  malfunction  

Event Description

Customer reported that while the alarm was in use with a patient, the patient got up from the chair and the device failed to alarm.Customer reported they have tested the device and it either never alarms or continuously alarms.Customer no longer has the sensor that was in use with the alarm.Customer tested the alarm with different sensors, but the issue persisted.No patient serious injury was reported.

Manufacturer Narrative

Product was requested to be returned for evaluation but has not been received.Note: this report is submitted based on the customer's reported issue statement.(b)(4).

• 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: mary segura ; 5635 peck rd.; arcadia, CA 91006 ; 6644333143
• MDR Report Key: 3966517
• MDR Text Key: 15118356
• Report Number: 2020362-2014-00228
• 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: 05/28/2014

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/28/2014
• Initial Date FDA Received: 06/26/2014
• Was Device Evaluated by Manufacturer?: No
• 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: CHAIR SENSOR, MODEL UNK, LOT #UNK
• Patient Age: 64 YR
• Patient Weight: 78