BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BERLIN HEART

    MDR report key: 9805365 · Received March 9, 2020

    Report

    Report Number
    9805365
    Event Type
    Malfunction
    Date Received
    March 9, 2020
    Date of Event
    December 16, 2019
    Report Date
    December 20, 2019
    Manufacturer
    BERLIN HEART, INC.
    Product Code
    PCK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    OUR PATIENT WITH A BERLIN HEART HAD A PUMP THAT WAS MAKING A CRUNCHING NOISE. VIDEO AND PICTURE OF THE PUMP WERE TAKEN AND SENT TO BERLIN HEART TO ASSESS. INITIALLY WE WERE TOLD THAT NO INTERVENTIONS WERE NEEDED. THE FOLLOWING DAY, WE RECEIVED A CALL FROM BERLIN HEART AND WERE TOLD THAT AFTER THEY FURTHER ASSESSED THE VIDEO AND IMAGES OF THE PUMP, WE SHOULD CHANGE IT OUT. SO THE PUMP WAS EXCHANGED WITH NO ISSUES OR HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270592 BERLIN HEART BERLIN HEART PCK BERLIN HEART, INC. BERLIN HEART 15CC PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 270 DA