BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPRESSOR MINI

    MDR report key: 3802677 · Received February 25, 2014

    Report

    Report Number
    8010042-2014-00056
    Event Type
    Malfunction
    Date Received
    February 25, 2014
    Date of Event
    February 11, 2014
    Report Date
    February 13, 2014
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    BTI
    PMA / PMN Number
    K023354
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL MEDWATCH WILL BE PROVIDED WHEN THE INVESTIGATION HAS BEEN FINALIZED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A BURNING SMELL AND THAT THE COMPRESSOR WOULD NOT CYCLE WHILE CONNECTED TO THE VENTILATOR SYSTEM DURING A PT TREATMENT. THERE WAS NO PT HARM. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115017 COMPRESSOR MINI BTI BTI MAQUET CRITICAL CARE AB NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI