BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMART MONITOR 2 PS

    MDR report key: 7273925 · Received February 15, 2018

    Report

    Report Number
    3006182632-2018-00001
    Event Type
    Malfunction
    Date Received
    February 15, 2018
    Report Date
    February 15, 2018
    Manufacturer
    CIRCADIANCE, LLC
    Product Code
    NPF
    UDI-DI
    B0361014557
    PMA / PMN Number
    K032403
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    UPON REVIEWING THE NURSE CALL (B)(6) IT IS OBVIOUS THAT THE (B)(6) WAS PHYSICALLY DAMAGED. THE ONLY PLAUSIBLE EXPLANATION FOR THE LEVEL OF DAMAGE SEE ON THE (B)(6) WOULD BE FOR THE UNIT TO HAVE SUFFERED AN IMPACT, SUCH AS BEING DROPPED, WITH THE NURSE CALL WYE CABLE CONNECTED TO THE NURSE CALL (B)(6). I SPOKE WITH THE COMPLAINANT ON (B)(6) 2018 AND SHE COULD NOT PROVIDE ANY SPECIFIC INFORMATION REGARDING THE DAMAGED NURSE CALL (B)(6). SHE ONLY INDICATED THAT NURSING WOULD SEND THE UNIT TO THE BIOMEDICAL DEPARTMENT NOTING THAT THE ALARM PORT WAS NOT WORKING. THE EXACT MECHANISM THAT NURSING USED TO DETERMINE THAT THE PORT WAS NOT FUNCTIONAL WAS NOT ABLE TO BE ASCERTAINED. WE ARE UNSURE IF THE DAMAGE WAS NOTICED WHEN THE UNIT WAS DROPPED OR AT SOME POINT IN TIME AFTER THE DAMAGE HAD OCCURRED. THIS FAILURE OF THE NURSE CALL (B)(6) DOES NOT COMPROMISE THE ABILITY OF THE MONITOR TO MONITOR AND DETECT ALARM CONDITIONS. THE PRIMARY ALARM SYSTEM IN THE MONITOR REMAINED FUNCTIONAL. THE PROFESSIONAL USER MANUAL CLEARLY INDICATES THAT THE NURSE CALL FEATURE IS PROVIDED FOR CONVENIENCE AND SHOULD NOT BE RELIED UPON AS THE PRIMARY ALARM SYSTEM.

    Description of Event or Problem · 1

    ON (B)(6) 2018 THE SPECIALTY HOSPITAL OF (B)(6) (A.K.A. (B)(6) HOSPITAL) RETURNED A SMART MONITOR 2PS INFANT APNEA MONITOR MODEL NUMBER 1014557 (SERIAL NUMBER (B)(4)) WITH THE COMPLAINT THAT THE REMOTE ALARM PORT DOES NOT WORK. THE CIRCADIANCE SERVICE TECHNICIAN CONFIRMED THE COMPLAINT AND DOCUMENTED THAT THE NURSE CALL (B)(6) IS DAMAGED. IF THE UNIT WAS USED WITH THE DAMAGED NURSE CALL (B)(6), THE MONITOR MAY NOT TRANSMIT AN ALARM TO THE HOSPITAL NURSE CALL SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    119242 SMART MONITOR 2 PS INFANT APNEA MONITOR NPF CIRCADIANCE, LLC 1014557 B0361014557

    Patients

    Seq Age Sex Outcome Treatment
    1 24 MO