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

Model Number	1038140
Medical Device Problem Code	Solder Joint Fracture (2324)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/01/2018
Type of Reportable Event	Malfunction
Event or Problem Description
A user facility reported that the nurse call jack on the monitor was not operating properly.

• Brand Name: SMART MONITOR 2PSL
• Common Device Name: INFANT APNEA MONITOR
• Manufacturer (Section D): CIRCADIANCE, LLC; 1300 rodi rd.; turtle creek PA 15145
• MDR Report Key: 8080927
• Report Number: 3006182632-2018-00027
• Device Sequence Number: 10817222
• Product Code: NPF
• UDI-Device Identifier: B0361038140
• UDI-Public: B0361038140
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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
• Remedial Action: Repair
• Type of Report: Initial
• Report Date (Section B): 11/16/2018

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: 1038140
• Device Catalogue Number: 1038140
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/01/2018
• Initial Report FDA Received Date: 11/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1