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

Model Number	4003
Medical Device Problem Code	No Audible Alarm (1019)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/03/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The smart monitor 2 devices incorporate a start up sequence where all audible and visual alarm indicators are activated to allow a user to verify that all of these elements function correctly every time the monitor is turned on to be put into service.The device that is the subject of this report was not in patient use when the audible alarm failure was detected suggesting that the start up sequence does provide an appropriate means for the user to determine whether or not the monitor's alarm systems are functioning properly.
Event or Problem Description
A user facility contacted circadiance on (b)(6) 2018 and reported that the audible alarm in the monitor was not functioning.The monitor was not being used with a patient when this issue was identified.
Additional Manufacturer Narrative
The alarm module manufacturer reviewed production records for the lot of modules associated with the failed alarm buzzer.All buzzers passed factory testing and no other failures have been received from this lot.The manufacturer determined that the appropriate corrective action for this issue was to re-train the operator as this solder joint is a manual operation.Based on the fact that only one buzzer from this lot has failed, no further action will be taken at this time.

• Brand Name: SMART MONITOR 2
• Common Device Name: INFANT APNEA MONITOR
• Manufacturer (Section D): CIRCADIANCE, LLC; 1300 rodi rd; turtle creek PA 15145
• MDR Report Key: 7826643
• Report Number: 3006182632-2018-00024
• Device Sequence Number: 13832196
• Product Code: FLS
• UDI-Device Identifier: B0364003
• UDI-Public: B0364003
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2018

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
• Device Catalogue Number: 4003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2018
• Initial Date Received by Manufacturer: 08/03/2018
• Supplement Date Received by Manufacturer: 08/03/2018
• Initial Report FDA Received Date: 08/29/2018
• Supplement Report FDA Received Date: 10/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1