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

Model Number	4003
Medical Device Problem Code	Device Alarm System (1012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complaint issue alleged by the customer was not able to be confirmed because the device has not been sent to circadiance for evaluation.The customer stated that the device will not be sent in for service and requested that the complaint record be closed.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 user of this equipment is responsible for reading, understanding, and following the warning and caution statements throughout the manual.No additional information is available at this time.If additional information becomes available or the device is sent to circadiance for evaluation, a follow-up report will be filed.
Event or Problem Description
Circadiance, llc received customer complaint allegation on (b)(6) 2016 detailing a product issue associated with a smartmonitor 2 device.The customer reported that the device failed to alarm during the functional self-test.No resulting effect on a patient or potential user has been reported.

• Brand Name: SMART MONITOR 2
• Common Device Name: APNEA MONITOR
• Manufacturer (Section D): CIRCADIANCE LLC; 1300 rodi road; turtle creek PA 15145
• MDR Report Key: 5871605
• Report Number: 3006182632-2016-00003
• Device Sequence Number: 1366242
• Product Code: FLS
• UDI-Device Identifier: B0364003
• UDI-Public: B0364003
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K011597
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 07/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 4003
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2016
• Initial Report FDA Received Date: 08/12/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1