BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPRESSOR MINI

    MDR report key: 17423011 · Received July 31, 2023

    Report

    Report Number
    8010042-2023-01456
    Event Type
    Malfunction
    Date Received
    July 31, 2023
    Report Date
    July 31, 2023
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    BTI
    UDI-DI
    7325710001523
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ON-SITE INVESTIGATION WAS PERFORMED AND IT WAS FOUND THAT THE ISSUE WAS RELATED TO DRAINAGE VALVE. THE ISSUE WAS RESOLVED BY REPLACING DRAINAGE VALVE AND THE DEVICE WAS DELIVERED TO THE USER IN WORKING CONDITION. THE DRAINAGE VALVE IS POWERED WITH 12 V AND ELECTRICALLY CONTROLLED BY THE PC BOARD. THE PURPOSE OF THE DRAINAGE VALVE IS TO REMOVE WATER COLLECTED IN THE WATER SEPARATOR AT REGULAR INTERVALS. THE VALVE IS CLOSED IN NON-ACTIVATED CONDITION. DURING OPERATION, THE VALVE WILL BE ACTIVATED (OPEN) FOR APPROX. 0.5 SECONDS TWICE EVERY MINUTE BY THE TIMING CIRCUIT ON THE PC BOARD. WHEN THE VALVE OPENS, THE WATER COLLECTED IN THE WATER SEPARATOR WILL BE TRANSPORTED TO THE DRAINAGE BOTTLE. NO PART WAS RETURNED TO THE FACTORY. THE ROOT CAUSE OF THE CLAIMED ISSUE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    MANUFACTURER'S REF. #: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE COMPRESSOR'S DRAINAGE VALVE WAS FOUND DEFECTIVE. THERE WAS NO PATIENT HARM. MANUFACTURER'S REF. #: 864144.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660646 COMPRESSOR MINI COMPRESSOR, AIR, PORTABLE BTI MAQUET CRITICAL CARE AB COMPR MINI 230V 50HZ 7325710001523

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown