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

Model Number	1028970
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Circadiance has chosen to report instances of nurse call jacks that are damaged but still remain mechanically intact to the point where a user would be able to make a physical connection to the nurse call jack.If the user did not verify that the connection to the nurse call system was made, the user facility personnel may rely on the nurse call alarm versus relying on the integral alarm in the monitor to decide when to act.This would be an unexpected action given that this would mean that trained medical staff would ignore a primary device alarm and only respond to alarms at a nurse call station.
Event or Problem Description
A user facility reported that "alarm connector broken inside alarm port" occurred on a smart monitor 2psl monitor, model 1028970, serial number (b)(4).The alarm port referred to by the customer in this complaint is a female jack that allows the monitor to be connected to a hospital nurse call system.In this case, the alarm port connections have been determined to be physically broken at the point where the jack is attached to the main circuit board.At least one of the connections is still intact.

• 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: 8080958
• Report Number: 3006182632-2018-00026
• Device Sequence Number: 1780124
• Product Code: NPF
• UDI-Device Identifier: B0361028970
• UDI-Public: B0361028970
• 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): 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: 1028970
• Device Catalogue Number: 1028970
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/13/2018
• 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