BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BERLIN HEART

    MDR report key: 6510794 · Received April 19, 2017

    Report

    Report Number
    MW5069239
    Event Type
    Injury
    Date Received
    April 19, 2017
    Date of Event
    February 15, 2017
    Report Date
    April 19, 2017
    Manufacturer
    BERLIN HEART
    Product Code
    PCK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    BERLIN VAD NOTED BY ALARMS AND STAFF NOT TO BE FUNCTIONING PROPERLY. VAD ASSESSED TO NOT BE EJECTING AND PATIENT WITH ACUTE DECOMPENSATION. MD AND SURGICAL TEAM CALLED TO BEDSIDE AND WITH IMMEDIATE RESPONSE AND SURGICAL INTERVENTION TO CHANGE VAD. POTENTIAL DELAMINATION OF MEMBRANE NOTED BY SURGEON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    285216 BERLIN HEART EXCOR VAD BERLIN HEART 15ML (VENTRICULAR ASSIST DEVICE) PCK BERLIN HEART REF P15P-001

    Patients

    Seq Age Sex Outcome Treatment
    1 5 MO Life Threatening