BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INVIA MOTION+ 15 DAYS SINGLE

    MDR report key: 7422605 · Received April 11, 2018

    Report

    Report Number
    1419937-2018-00104
    Event Type
    Malfunction
    Date Received
    April 11, 2018
    Date of Event
    January 24, 2018
    Report Date
    April 11, 2018
    Manufacturer
    MEDELA AG
    Product Code
    OMP
    PMA / PMN Number
    K161128
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS REQUESTED FOR RETURN. THE CUSTOMER DID NOT WANT A REPLACEMENT DEVICE. 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 A PATIENT HAD THE PUMP SQUEEZED BETWEEN THEIR LEG AND A CHAIR AND THE PUMP FELT WARM AND WASN'T WORKING ON BATTERY POWER. AFTER APPROXIMATELY 45 MINUTES, THE PUMP BEGAN WORKING AGAIN ON BATTERY POWER. THE CUSTOMER INDICATED THAT 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
    266269 INVIA MOTION+ 15 DAYS SINGLE NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP OMP MEDELA AG 0874012

    Patients

    Seq Age Sex Outcome Treatment
    1