BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECARECOMPANION

    MDR report key: 6345784 · Received February 21, 2017

    Report

    Report Number
    1125873-2017-00003
    Event Type
    Malfunction
    Date Received
    February 21, 2017
    Date of Event
    January 27, 2017
    Report Date
    January 30, 2017
    Manufacturer
    VISICU, INC - DUP
    Product Code
    DXN
    PMA / PMN Number
    K043217
    Adverse Event
    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 A PATIENT INJURED WITH THE ECARE COMPANION BLOOD PRESSURE (BP) CUFF DEVICE. THE DEVICE WAS RETURNED TO THE 3RD PARTY LOGISTICS SUPPLIER (3PL) (B)(4) ON MARCH 9, 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 SHOWED THAT PATIENT'S LAST MEASUREMENT WAS THE 29TH. CUFF SIZE WAS CORRECT FOR THE DEVICE. PER THE HHA, THE DEVICE APPEARED TO OVERINFLATE. PATIENT IS CURRENTLY PENDING REMOVAL OF DEVICES. PATIENT WAS ON SERVICE FOR 9 DAYS PRIOR TO INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    130097 ECARECOMPANION ECAD BP MEDIUM/LG DXN VISICU, INC - DUP 453564551731

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Other