BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE AIR COMPRESSOR FOR MEDICAL PURPOSES

    MDR report key: 4243645 · Received November 11, 2014

    Report

    Report Number
    3008262382-2014-01951
    Event Type
    Malfunction
    Date Received
    November 11, 2014
    Report Date
    October 21, 2014
    Manufacturer
    INVACARE REHABILITATION EQUIP
    Product Code
    BTI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    END USER REPORTED THAT THE TUBING FOR THEIR (B)(4) AEROSOL COMPRESSOR KEEPS BLOWING OFF, THE UNIT ALLEGEDLY GETS HOT AND IS GETTING VERY NOISY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    727160 PORTABLE AIR COMPRESSOR FOR MEDICAL PURPOSES 868.6250 BTI INVACARE REHABILITATION EQUIP IRC1705

    Patients

    Seq Age Sex Outcome Treatment
    1 Other