MAUDE Adverse Event Report: CIRCADIANCE LLC SMARTMONITOR 2; APNEA MONITOR

Model Number 4002

Device Problems Device Alarm System (1012); No Audible Alarm (1019)

Patient Problem No Patient Involvement (2645)

Event Date 06/29/2015

Event Type  malfunction  

Manufacturer Narrative

The alarm module has been returned to the manufacturer for analysis.Results of that analysis 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 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.

Event Description

Circadiance, llc received a customer complaint on (b)(6) 2915 where it was alleged that a smartmonitor 2 unit was not producing an audile alarming.The unit was sent back to circadiance.Upon inspection of the device, it was determined that the device was not producing an audible alarm.A circadiance representative contacted the customer to get additional details.The customer did not know if the device was in use at the time the problem was discovered and no patient harm was alleged.

Manufacturer Narrative

Circadiance, llc has completed its investigation of the smartmonitor 2 device.The investigation concluded that the identified issue was associated with a quality manufacturing issue previously identified by the supplier of the component.The supplier had implemented a corrective action associated with this failure and determined that the corrective action was effective.The failure of the device had been previously identified in the product's risk analysis and product labeling.An evaluation of the risk associated with the identified failure has determined that there is no new or increased risk to the patient or user and that no additional risk reduction is necessary.Based on a complete review of the complaint allegation and the supplier's corrective action, it has been concluded that the identified failure is not considered to be a systemic issue and that the associated risk has been found to be acceptable.Complaint tracking and trending will continue to be monitored on a periodic basis.Circadiance, llc has determined that no further investigation or action is required at this time.

• Brand Name: SMARTMONITOR 2
• Type of Device: APNEA MONITOR
• Manufacturer (Section D): CIRCADIANCE LLC; 1060 corporate lane; export PA 15632
• Manufacturer Contact: james gianoutsos ; 1300 rodi road; turtle creek, PA 15145 ; 7243879182
• MDR Report Key: 5018686
• MDR Text Key: 23938734
• Report Number: 3006182632-2015-00001
• Device Sequence Number: 1
• Product Code: FLS
• 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: Followup
• Report Date: 08/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4002
• Device Catalogue Number: 4002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/15/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2008
• 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