BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPRESSOR MINI

    MDR report key: 7666282 · Received July 6, 2018

    Report

    Report Number
    8010042-2018-00333
    Event Type
    Malfunction
    Date Received
    July 6, 2018
    Date of Event
    June 24, 2018
    Report Date
    September 17, 2018
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    BTI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    GETINGE USA SALES, LLC (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF MAQUET CRITICAL CARE AB (MANUFACTURER). REF. EXEMPTION #: E2018003. GETINGE USA SALES, LLC 45 BARBOUR POND DRIVE WAYNE, NJ 07470. CONTACT PERSON: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN CONNECTED TO A VENTILATOR, THE COMPRESSOR WAS FREQUENTLY SWITCHING TO STANDBY MODE. THERE WAS NO PATIENT HARM. (B)(4).

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE PROBLEM DESCRIPTION, THE COMPRESSOR MINI WAS CYCLING IN AND OUT OF STANDBY MODE. THE PROBLEM WAS CONFIRMED ON-SITE, THE STANDBY VALVE WAS REPLACED AND AFTER THAT WAS FUNCTIONAL TESTS PERFORMED SUCCESSFULLY AND THE COMPRESSOR UNIT WAS RETURNED TO SERVICE. THE STANDBY VALVE WAS NOT RETURNED FOR INVESTIGATION. RECEIVED DEVICE LOGS UNDERPINS THE REPORTED ISSUE. ALARMS FOR LOW AIR SUPPLY PRESSURE AND HIGH OXYGEN CONCENTRATION CAN BE CONFIRMED INDICATING INSUFFICIENT AIR SUPPLY. THE STANDBY VALVE SHALL PUT THE COMPRESSOR IN STANDBY WHEN WALL AIR IS CONNECTED AND SHALL START TO SUPPLY COMPRESSED AIR WHEN NO WALL AIR IS CONNECTED. BASED ON PRIOR INVESTIGATIONS, THE MOST PROBABLE CAUSE TO THIS FAILURE IS A LEAKAGE IN THE VALVE PISTON RESULTING IN WRONG PRESSURE MEASUREMENT. HOWEVER, THE TRUE ROOT CAUSE CANNOT BE DETERMINED WITHOUT INVESTIGATING THE STANDBY VALVE. (B)(4). REF. EXEMPTION #: E2018003. (B)(4).

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    510255 COMPRESSOR MINI COMPRESSOR, AIR, PORTABLE BTI MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1