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

Model Number	4002
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Apnea (1720)
Date of Event	06/23/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At this time, there is no evidence that the monitor caused or contributed to the reported fire and resultant caregiver injury.Circadiance is seeking an outside expert to further analyze the monitor to either corroborate or alter the conclusions derived from our internal analysis.Given that a documented caregiver injury was reported, circadiance has chosen to file an mdr report with the fda even though there is no indication that the monitor malfunctioned and/or caused or contributed to reported caregiver's injury.
Event or Problem Description
(b)(6) contacted circadiance to report that a smart monitor 2 infant apnea monitor and an oxygen cylinder had been involved in a "flash fire".The following text is copied from the submission form received from (b)(6): "this devise (sic) was used at the same time an oxygen tank emitted a flash fire.The mothers (sic) foot was burned no injury to the child or anyone else.The apnea monitor continued to work without interruption.Please do a full investigation of equipment with a detailed report of the functionality of apnea monitor." a follow up call to (b)(6) revealed that the patient's mother experienced a second degree burn on her foot and required treatment at a hospital.Circadiance is not aware of whether or not the mother was admitted to the hospital or if treatment was administered in the emergency department.There is no reported injury to the infant patient as a result of this event.

• Brand Name: SMART MONITOR 2
• Common Device Name: INFANT APNEA MONITOR
• Manufacturer (Section D): CIRCADIANCE; 1300 rodi rd.; turtle creek PA 15145
• MDR Report Key: 7833862
• Report Number: 3006182632-2018-00023
• Device Sequence Number: 1338668
• Product Code: FLS
• UDI-Device Identifier: B0364002
• UDI-Public: B0364002
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Other
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 07/05/2018

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: No Information
• Device Model Number: 4002
• Device Catalogue Number: 4002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2018
• Initial Date Received by Manufacturer: 06/26/2018
• Supplement Date Received by Manufacturer: 06/26/2018
• Initial Report FDA Received Date: 08/30/2018
• Supplement Report FDA Received Date: 10/04/2018
• 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