MAUDE Adverse Event Report: J. T. POSEY CO. FLOOR SENSOR MAT, LARGE; KMI

Model Number 8250L

Device Problem Device Damaged Prior to Use (2284)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

Customer reported the sensor is not sending a signal to the alarm.The issue was discovered during set up, but the date of the event is unk.No patient incident or injury was reported.

Manufacturer Narrative

Product was requested to be returned for evaluation, but has not been received.Note: this submission is based solely on the user facility reported issue.(b)(4).

• Brand Name: FLOOR SENSOR MAT, LARGE
• Type of Device: KMI
• Manufacturer (Section D): J. T. POSEY CO.; arcadia CA
• Manufacturer Contact: mary segura ; 5635 peck rd.; arcadia, CA 91006 ; 6264433143
• MDR Report Key: 4202406
• MDR Text Key: 15363860
• Report Number: 2020362-2014-00314
• 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: Other
• Type of Report: Initial
• Report Date: 08/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8250L
• Device Catalogue Number: 8250L
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/21/2014
• 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: KEEPSAFE DELUXE ALARM, MODEL: PN 8374, SERIAL#:UNK