BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INVIA MOTION+ ENDURE SINGLE

    MDR report key: 8491395 · Received April 8, 2019

    Report

    Report Number
    1419937-2019-00059
    Event Type
    Malfunction
    Date Received
    April 8, 2019
    Date of Event
    November 20, 2018
    Manufacturer
    MEDELA AG
    Product Code
    OMP
    UDI-DI
    07612367052849
    PMA / PMN Number
    K161128
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 WHEN THE MOTION NEGATIVE PRESSURE WOULD THERAPY DEVICE WAS NOT PLUGGED INTO AN ELECTRICAL OUTLET, IT POWERED DOWN AND WOULD NOT POWER BACK ON, THOUGH APPROXIMATELY 30 MINUTES LATER IT POWERED ON WITHOUT PROMPTING. THOUGH THE ISSUE OCCURRED WHILE ON A PATIENT, 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
    283646 INVIA MOTION+ ENDURE SINGLE NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP OMP MEDELA AG 0874010 NI 07612367052849

    Patients

    Seq Age Sex Outcome Treatment
    1