BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMART MONITOR 2PS

    MDR report key: 7402953 · Received April 6, 2018

    Report

    Report Number
    3006182632-2018-00009
    Event Type
    Malfunction
    Date Received
    April 6, 2018
    Date of Event
    February 2, 2018
    Report Date
    March 28, 2018
    Manufacturer
    CIRCADIANCE, LLC
    Product Code
    NPF
    UDI-DI
    B0361030271
    PMA / PMN Number
    K061256
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    (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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    245008 SMART MONITOR 2PS INFANT APNEA MONITOR NPF CIRCADIANCE, LLC 1030271 B0361030271

    Patients

    Seq Age Sex Outcome Treatment
    1 1 MO