MAUDE Adverse Event Report: CIRCADIANCE, LLC SMARTMONITOR 2 W/O MODEM; APNEA MONITOR

Model Number 4002

Device Problems Device Alarm System (1012); Defective Alarm (1014)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/06/2015

Event Type  malfunction  

Event Description

Circadiance, (b)(4) received a customer complaint on (b)(6) 2015 where it was alleged that a smartmonitor 2 unit was not producing an audible alarm.The unit was sent back to circadiance, (b)(4).Upon inspection of the device, it was determined that the device was producing an audible alarm; however, the alarm sound was distorted.The customer stated that the device was in use at the time the problem was discovered and no patient or user harm was alleged or had occurred.The alarm module has been returned to the manufacturer for further investigation.Results of the investigation will be provided in a follow up report.The smartmonitor 2 device has provisions to allow the user to detect failure of the audible alarm.Specifically, the users are instructed that the audible alarm will annunciate every time that the monitor is turned on allowing the user to verify alarm functionality prior to placing the device into service.Additionally, users are instructed to perform a full device checkout by following the published smartmonitor 2 checkout procedure between uses on different patients or at least annually if the monitor has not been in use.The steps of the checkout procedure fully verify all of the alarm functions of the smartmonitor 2.These instructions and features minimize the risk that an audible alarm failure can result in patient injury.The instructions and features notified the caregiver and subsequently returned the device for servicing.

Manufacturer Narrative

Circadiance, llc has completed its investigation of the smartmonitor 2 product failure detailed in the initial medwatch submission.The investigation concluded that the identified issue could not be substantiated by the components manufacturer.Testing of the component concluded that it was found to operate and perform to specification.No operational issues signifying a malfunction were recorded during the manufacturer's investigation.The operator's manual recommends that before you use the smart monitor 2, test to see if you can hear the alarm in different rooms while there is noise in your house.The operator's manual recommends to always keep the area in front of the speaker clear and to turn the monitor on (without the child attached) to sound the alarm, making sure you can hear the alarm in different areas of your home.Circadiance has determined that based on a complete review of the available information, it is concluded that use of the device does not present an increased risk to the end user or patient and that no corrective action or additional investigation activity is necessary at this time.

• Brand Name: SMARTMONITOR 2 W/O MODEM
• Type of Device: APNEA MONITOR
• Manufacturer (Section D): CIRCADIANCE, LLC; 1060 corporate lane; export PA 15632
• Manufacturer (Section G): CIRCADIANCE, LLC; 1060 corporate lane; export PA 15632
• Manufacturer Contact: james gianoutsos ; 1060 corporate lane; export, PA 15632 ; 7243879182
• MDR Report Key: 5284898
• MDR Text Key: 33113655
• Report Number: 3006182632-2015-00004
• Device Sequence Number: 1
• Product Code: FLS
• UDI-Device Identifier: B0364002
• UDI-Public: B0364002
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K011597
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 4002
• Device Catalogue Number: 4002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/13/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/29/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1