MAUDE Adverse Event Report: RF|TECHNOLOGIES SAFE PLACE INFANT AND PEDIATRIC SECURITY SOLUTIONS; SAFE PLACE SECURITY

Model Number 9450-6262H

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 09/25/2015

Event Type  malfunction  

Event Description

This is being reported as a product patient safety concern.Our facility purchased the rf|technologies safe place infant and pediatric security system and have had concerns with them functioning properly.We have contacted the representative and continue to have problems with them functioning properly after they have been checked out.We order about (b)(4) a year and they are supposed to have a battery life of a year.What is reported to risk is the following.Sensor 14 kept saying lost signal.Sensor taken out of service.The following information is on the safe place sensor for sensor #14: exp.6/2016.Identifying information on side of sensor: (b)(4).

• Brand Name: SAFE PLACE INFANT AND PEDIATRIC SECURITY SOLUTIONS
• Type of Device: SAFE PLACE SECURITY
• Manufacturer (Section D): RF|TECHNOLOGIES; 3125 north 126th st; brookfield WI 53005
• MDR Report Key: 5187301
• MDR Text Key: 29939283
• Report Number: MW5057479
• Device Sequence Number: 1
• Product Code: KMI
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2016
• Device Model Number: 9450-6262H
• Device Catalogue Number: KXU-CBTX2
• Device Lot Number: 0510-1086-I
• Other Device ID Number: 2719A-CBTX2
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1