BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREEMIE PUMP

    MDR report key: 8384460 · Received March 2, 2019

    Report

    Report Number
    3007602316-2019-00003
    Event Type
    Malfunction
    Date Received
    March 2, 2019
    Date of Event
    November 19, 2018
    Report Date
    November 19, 2018
    Manufacturer
    DAO HEALTH
    Product Code
    HGX
    UDI-DI
    00851690007455
    PMA / PMN Number
    K172772
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NONE.

    Description of Event or Problem · 1

    ON (B)(6) 2018 - CUSTOMER REPORTED THAT DEVICE WAS OVERHEATING. DEVICE WAS CLASSIFIED AS A "PUMP NOT WORKING" PER MDR ASSESSMENT THIS EVENT WAS NOT REPORTABLE. ON 12/03/2018 - DEVICE RECEIVED BY DAO HEALTH. ON 12/12/2018 - DEVICE WAS INVESTIGATED AND FOUND TO BE "LOW SUCTION MOTOR AND NOT GETTING POWER FROM THE BOARD (DID INITIALLY, THEN STOPPED). MOTOR RUNS ON THE POWER SUPPLY (BUT ONLY MAKES ABOUT 3 INHG). THE BOARD MAKES 6 VOLTS WHEN MEASURED AT THE PINS BUT DOES NOT RUN THE MOTOR." ON 02/04/2019 - DURING REVIEW OF THE ENGINEERING LOG, ENGINEERING DECIDED TO REVIEW THIS COMPLAINT AGAIN AND EXAMINED THE DEVICE. FURTHER INVESTIGATION DETERMINED THE "Q5 CHIP LOOKS LIKE IT MIGHT BE A LITTLE FRIED". FAILURE OF THE Q5 CHIP IS THE ROOT CAUSE FOR DAO HEALTH COMPLAINT CODE "SMOKING PUMP". ENGINEERING PROMPTLY NOTIFIED QUALITY SO THAT MDR COULD BE FILED. ON 02/04/2019 - BASED ON NEW INFORMATION, QUALITY BEGAN COLLECTION INFORMATION SO AN MDR COULD BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    177461 FREEMIE PUMP FREEMIE LIBERTY DELUXE SET HGX DAO HEALTH FG077 16.07.18-10 00851690007455

    Patients

    Seq Age Sex Outcome Treatment
    1 Other