BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASPIRATOR MOBILAIRE 9153619936

    MDR report key: 4353518 · Received December 22, 2014

    Report

    Report Number
    1531186-2014-06698
    Event Type
    Malfunction
    Date Received
    December 22, 2014
    Report Date
    November 6, 2014
    Manufacturer
    EMG TECHNOLOGY CO. LTD
    Product Code
    GCY
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED BY A DEALER THAT AN (B)(4) ASPIRATOR HAS LOW SUCTIONING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    841393 ASPIRATOR MOBILAIRE 9153619936 APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED GCY EMG TECHNOLOGY CO. LTD IRC1135

    Patients

    Seq Age Sex Outcome Treatment
    1 Other