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

Model Number	1028970
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Circadiance was not able to replicate the customer's complaint.The nurse call output was found to be working properly.A follow up phone call with the customer was made to discuss the issue to determine if any other aspects of the installation might have impacted the alarm signal transmission.The customer described a connection between their nurse call system and the monitor that seemed to be appropriate.During the conversation, the customer was asked to test the monitor when it is received back from circadiance to verify that they agree that the monitor is working as intended.The customer was also asked to test multiple interface cables at their site to see if an interface cable may be malfunctioning.Circadiance has chosen to report this incident since the actual cause of the failure to transmit the alarm has not been determined.If the customer provides follow up information regarding testing with interface cables in their facility, a follow up report will be filed.
Event or Problem Description
Saint francis health system reported that a smart monitor 2ps, model number 1028970, serial number (b)(4) had an auxilliary alarm interface that was not working.The biomed reported that staff informed biomed that the alarm would not call the desk through the nurse call system.The biomed reported that she visited the location where the monitor was used and verified that alarms were not being transmitted to through the nurse call system.The biomed also reported that the primary alarm in the monitor was working.

• Brand Name: SMART MONITOR 2PSL
• Common Device Name: INFANT APNEA MONITOR
• MDR Report Key: 7318882
• Report Number: 3006182632-2018-00008
• Device Sequence Number: 19233782
• Product Code: NPF
• UDI-Device Identifier: B0361028970
• UDI-Public: B0361028970
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K061256
• 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): 03/06/2018

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: 1028970
• Device Catalogue Number: 1028970
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/06/2018
• Initial Report FDA Received Date: 03/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 5 DA