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

Model Number	4003
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As of the date of this investigation, circadiance has not been able to determine the medical reason for the patient "turning blue".As such, circadiance has decided to classify this event as a reportable event to the fda even though there is no evidence that the monitor in question was malfunctioning as we are not able to determine if the reported "failure to alarm" was in fact related to the monitor or a patient condition that is not detectable by the monitor such as an airway obstruction.
Event or Problem Description
Infant was reported to have been monitored by the device in question.The parents reported to the durable medical equipment provider that the baby was found blue and the monitor was not alarming.The patient was transported to the hospital and admitted.There was no permanent injury reported to circadiance and the patient was reported to have been discharged back home the day after admission.

• Brand Name: SMART MONITOR 2
• Common Device Name: INFANT APNEA MONITOR
• Manufacturer (Section D): CIRCADIANCE, LLC; 1300 rodi road; turtle creek PA 15145
• MDR Report Key: 7486197
• Report Number: 3006182632-2018-00010
• Device Sequence Number: 11253623
• Product Code: FLS
• UDI-Device Identifier: B0364002
• UDI-Public: B0364002
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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,user faci
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 05/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Patient Family Member or Friend
• Device Model Number: 4003
• Device Catalogue Number: 4003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/13/2018
• Initial Report FDA Received Date: 05/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 2 MO