BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INVIA MOTION+ 15 DAYS SINGLE

    MDR report key: 8560058 · Received April 29, 2019

    Report

    Report Number
    1419937-2019-00069
    Event Type
    Malfunction
    Date Received
    April 29, 2019
    Date of Event
    August 30, 2018
    Manufacturer
    MEDELA AG
    Product Code
    OMP
    UDI-DI
    07612367053167
    PMA / PMN Number
    K161128
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS REQUESTED FOR RETURN AND A REPLACEMENT DEVICE WAS SENT TO THE CUSTOMER. AN EVALUATION OF THE DEVICE CONFIRMED THAT THIS COMPLAINT IS RELATED TO AN ISSUE IN WHICH OTHERWISE FULLY FUNCTIONING PUMPS DISPLAY A BATTERY MISSING ERROR NOTIFICATION, WHICH CAN BE CAUSED BY REPETITIVE UNPLUGGING AND PLUGGING WHEN THE BATTERY IS FULLY CHARGED. THIS SITUATION CAN POTENTIALLY LEAD TO A THERAPY INTERRUPTION. THE USER IS NOTIFIED OF SUCH A MALFUNCTION VIA AN AUDIBLE AND VISUAL NOTIFICATION AND IS INSTRUCTED VIA THE INSTRUCTIONS FOR USE TO CONTACT THEIR HEALTHCARE PROVIDER IN ORDER TO RECEIVE A REPLACEMENT DEVICE.

    Description of Event or Problem · 1

    ON (B)(6) 2018, THE CUSTOMER ALLEGED TO MEDELA LLC THAT THE INVIA MOTION NEGATIVE PRESSURE WOUND THERAPY DEVICE WAS GETTING HOT AND WAS NOT FULLY CHARGING WHILE ON A PATIENT; THOUGH, THERE WAS NO SERIOUS INJURY, THE PATIENT DID NOT EXPERIENCE WOUND DETERIORATION AND THE PATIENT DID NOT REQUIRE CONSULTATION AND/OR TREATMENT BY A MEDICAL PROFESSIONAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    354170 INVIA MOTION+ 15 DAYS SINGLE NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP OMP MEDELA AG 0874012 07612367053167

    Patients

    Seq Age Sex Outcome Treatment
    1