BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECARECOMPANION

    MDR report key: 6345781 · Received February 21, 2017

    Report

    Report Number
    1125873-2017-00002
    Event Type
    Injury
    Date Received
    February 21, 2017
    Report Date
    January 30, 2017
    Manufacturer
    VISICU, INC - DUP
    Product Code
    DXN
    PMA / PMN Number
    K043217
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    PHILIPS Q&R HAS COMPLETED THE INVESTIGATION FOR THE REPORTED FAILURE OF AN ECARE COMPANION BLOOD PRESSURE (BP) CUFF DEVICE OVERINFLATING AND CAUSING BRUISING. THE DEVICE WAS RETURNED TO THE 3RD PARTY LOGISTICS SUPPLIER (3PL) IQOR ON (B)(6) 2017. THE BP CUFF PASSED ALL TESTS WITH APPROPRIATE READINGS. THIS COMPLAINT COULD NOT BE CONFIRMED. Q&R WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    INVESTIGATION REVEALED THAT THE BRUISING WAS PRESENT AFTER THE READINGS WERE TAKEN, NOT PRIOR. PER HHA CUFF APPEARED TO BE OVERINFLATING. TRANSMISSION STOPPED ON THE (B)(6) AFTER 12 DAYS OF SERVICE. CUSTOMER IS CURRENTLY BEING REMOVED FROM SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    128844 ECARECOMPANION ECAD BP MEDIUM/LG DXN VISICU, INC - DUP 453564551731

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Other