MAUDE Adverse Event Report: POSEY PRODUCTS LLC ALARM SENSOR, CHAIR SENSOR PAD SQUARE 30-DAY; MONITOR, BED PATIENT

Model Number 8309

Device Problem Failure to Sense (1559)

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

Event Type  malfunction  

Manufacturer Narrative

Without the return of the device, the complaint cannot be confirmed.Based on previous complaint investigations of no sound or not sounding when it should, it can be speculated that a damaged rj11 clip or folds and creases on the sensor, may have contributed to the reported issue.All complaints are trended and reviewed by management on a monthly basis.As part of this monthly review, any excursion above the control limits for this failure mode will be assessed, documented and acted upon as warranted.Manufacturer reference file # (b)(4).Q4 2017 asr report #e2015006.Product not returned.

Event Description

This report summarizes one malfunction event.This report is for a sensor that is not sending a signal to the alarm.Q4 2017 asr report #e2015006.

• Brand Name: ALARM SENSOR, CHAIR SENSOR PAD SQUARE 30-DAY
• Type of Device: MONITOR, BED PATIENT
• Manufacturer (Section D): POSEY PRODUCTS LLC; arcadia CA
• Manufacturer Contact: william hincy ; posey company; 5635 peck road; arcadia, CA 91006 ; 6264433143
• MDR Report Key: 7223820
• MDR Text Key: 98848079
• Report Number: 2020362-2018-00007
• Device Sequence Number: 1
• Product Code: KMI
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial
• Report Date: 01/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2018
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 8309
• Device Catalogue Number: 8309
• Date Manufacturer Received: 01/22/2018
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1