BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMART MONITOR 2PSL

    MDR report key: 8080958 · Received November 16, 2018

    Report

    Report Number
    3006182632-2018-00026
    Event Type
    Malfunction
    Date Received
    November 16, 2018
    Report Date
    August 28, 2018
    Manufacturer
    CIRCADIANCE, LLC
    Product Code
    NPF
    UDI-DI
    B0361028970
    PMA / PMN Number
    K061256
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    921162 SMART MONITOR 2PSL INFANT APNEA MONITOR NPF CIRCADIANCE, LLC 1028970 B0361028970

    Patients

    Seq Age Sex Outcome Treatment
    1