BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EARLYSENSE

    MDR report key: 6165304 · Received December 11, 2016

    Report

    Report Number
    3008693420-2016-00002
    Event Type
    Malfunction
    Date Received
    December 11, 2016
    Date of Event
    October 12, 2016
    Report Date
    November 15, 2016
    Manufacturer
    EARLYSENSE LTD.
    Product Code
    OUG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2016 IT WAS REPORTED BY USERS AT (B)(6) THAT EARLYSENSE DEVICE PROVIDED A BED EXIT ALERT FOR A PATIENT THAT LEFT BED. THE EARLYSENSE CENTRAL DISPLAY STATION (CDS), ALSO PROVIDED THE BED EXIT ALERT AT THE SAME TIME AT THE NURSING STATION. ALERT WAS CONFIRMED AT THE BEDSIDE AND AT THE CDS BY HEALTHCARE PROVIDERS. NO INJURIES WERE REPORTED, HOWEVER, THE CUSTOMER REPORTED THAT THE EXTERNAL WIRELESS COMMUNICATION DEVICES ((B)(6)) DID NOT RECEIVE THE ALERTS ON ALL THREE TECH PHONES. IN CONCLUSION: THE EARLYSENSE BEDSIDE UNIT AND CENTRAL DISPLAY STATION WERE PERFORMING AS EXPECTED ACCORDING TO THEIR SPECIFICATIONS. HOWEVER, THE GATEWAY SOFTWARE WAS NOT SUPPORTING THE DELIVERY OF THE EARLYSENSE ALERTS TO THE EXTERNAL MOBILE ALERTING DEVICES THAT BELONG TO THE HOSPITAL ((B)(6)). CORRECTION PROVIDED TO THE SITE. UPDATED GATEWAY SOFTWARE WAS INSTALLED IN COLLABORATION WITH THE HOSPITAL IT THAT RECOGNIZES WHEN THE GATEWAY APPLICATION IS "DOWN' (WATCHDOG) AND RESTARTS THE GATEWAY SO THE EXTERNAL ALERTING DEVICES ARE SUPPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    816203 EARLYSENSE MEDICAL DEVICE DATA SYSTEM - GATEWAY OUG EARLYSENSE LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1