BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACHIEVA PLUS

    MDR report key: 3946333 · Received July 10, 2014

    Report

    Report Number
    8020893-2014-01644
    Event Type
    Injury
    Date Received
    July 10, 2014
    Date of Event
    January 1, 2014
    Report Date
    June 12, 2014
    Manufacturer
    COVIDIEN, FORMERLY NELLCOR PURITAN
    Product Code
    CBK
    PMA / PMN Number
    K990177
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COVIDIEN CUSTOMER SUPPORT ENGINEER (CSE) EVALUATED THE DEVICE AND COULD NOT DUPLICATE THE REPORTED COMPLAINT OF AN ELECTRICAL SHOCK. THE UNIT WAS CONNECTED TO AN ALTERNATE CURRENT (AC) OUTLET, AND POWERED UP. THE MULTIMETER WAS CONNECTED TO SEVERAL POINTS ON THE UNIT HOUSING, AND NO CURRENT OR VOLTAGE WAS FOUND. THE UNIT WAS SET TO VENTILATE, AND ALLOWED TO RUN OVERNIGHT, AND WAS CHECKED AGAIN FOR CURRENT AND VOLTAGE WITH NONE FOUND. ELECTRICAL SAFETY TEST WAS PERFORMED, AND THE VENTILATOR PASSED ALL TESTS. THE VENTILATOR WAS AGAIN CONNECTED TO AN AC OUTLET, AND ALLOWED TO VENTILATE OVERNIGHT. THE NEXT MORNING, AN ELECTRICAL SAFETY TEST WAS PERFORMED A SECOND TIME, AND UNIT PASSED ALL TESTS. DURING VISUAL INSPECTION, IT WAS OBSERVED THAT THE PRONGS ON THE AC CORD WERE BENT. THE CSE REPLACE THE AC CORD. THE UNIT PASSED ALL TESTS AND CALIBRATIONS, AND IT WAS OBSERVED TO BE OPERATING WITHIN MANUFACTURING SPECIFICATIONS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY A CUSTOMER IN THE USA THAT, DURING USE ON A HOMECARE PATIENT, THE CLINICIAN PLACED HER HAND ON THE FRONT RIGHT TOP CORNER OF THE ACHIEVA VENTILATOR AND FELT AN ELECTRICAL SHOCK. THE INCIDENT WAS REPORTED TO THE HOMECARE PROVIDER ON (B)(6) 2014. HOWEVER, THE INCIDENT TOOK PLACE PRIOR TO THIS DATE (DATE UNK). UPON BEING NOTIFIED OF THE INCIDENT, THE HOMECARE PROVIDER HAD THE VENTILATOR REPLACED. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404382 ACHIEVA PLUS CONTINUOUS VENTILATOR CBK COVIDIEN, FORMERLY NELLCOR PURITAN ACHIEVA PLUS

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention