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

Model Number	1030271
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/02/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The nurse call jack in this monitor was physically damaged rendering the output inoperable.Circadiance has recently re-evaluated reporting decisions related to physically damaged nurse call jacks.Circadiance has made the decision to report these instances of damaged nurse call jacks where the jack is still physically intact and it is possible that the user may have perceived that they were still able to make a connection to the jack.This complaint was received prior to the re-evaluation of reporting, however, the event occurred relatively recently.Thus circadiance has re-classified this complaint and has retrospectively filed this report to be consistent with the recent internal changes regarding reporting these events.The primary alarm in this monitor as well as all of the monitoring parameters were confirmed to be operating according to specification.
Event or Problem Description
(b)(6) hospital sent a smart monitor 2ps model number 1030271, serial number (b)(4) in for service requesting that circadiance check the overall performance of the monitor.The customer did not allege that the product was malfunctioning.They just requested that the device be evaluated.During service evaluation, the service technician determined that the nurse call jack was partially dislodged from the main circuit board rendering the nurse call output nonfunctional.

• Brand Name: SMART MONITOR 2PS
• Common Device Name: INFANT APNEA MONITOR
• Manufacturer (Section D): CIRCADIANCE, LLC; 1300 rodi rd.; turtle creek PA 15145
• MDR Report Key: 7402953
• Report Number: 3006182632-2018-00009
• Device Sequence Number: 2156602
• Product Code: NPF
• UDI-Device Identifier: B0361030271
• UDI-Public: B0361030271
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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): 03/28/2018

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: 1030271
• Device Catalogue Number: 1030271
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/30/2018
• Initial Report FDA Received Date: 04/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 1 MO