BEUDAMED
    FDA Adverse Event Summary report: N

    SUCTION APPARATUS, PATIENT CARE

    MDR report key: 3130631 · Received May 24, 2013

    Report

    Report Number
    1531186-2013-02319
    Date Received
    May 24, 2013
    Report Date
    May 1, 2013
    Manufacturer
    EMG TECHNOLOGY CO. LTD
    Product Code
    DWM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - FOLLOW UP #001. INITIAL PR (B)(4) ISSUED MFR. REPORT # 1531186-2013-02319, INDICTING THE BRAND NAME OF THE PRODUCT AS A PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL) WITH THE COMMON DEVICE NAME AS 868.5440. THE CORRECT BRAND NAME IS SUCTION APPARATUS, PATIENT CARE FOR AN ASPIRATOR, COMMON DEVICE NAME IS 870.5050.

    Description of Event or Problem · 1

    PER DEALER, NO POWER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231287 SUCTION APPARATUS, PATIENT CARE 870.5050 DWM EMG TECHNOLOGY CO. LTD IRC1135

    Patients

    Seq Age Sex Outcome Treatment
    1 Other