BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPRESSOR MINI

    MDR report key: 8074005 · Received November 15, 2018

    Report

    Report Number
    8010042-2018-00610
    Event Type
    Malfunction
    Date Received
    November 15, 2018
    Report Date
    December 14, 2018
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    BTI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPRESSOR WAS NOT INVESTIGATED BY OUR FIELD SERVICE ENGINEER. THE USER FACILITY PERFORMS THEIR OWN REPAIR AND SERVICE. NO LOGS FROM CONNECTED VENTILATOR HAVE BEEN PROVIDED AND NO PARTS WERE RETURNED FOR INVESTIGATION. THE USER FACILITY WAS RECOMMENDED TO REPLACE THE FITTING TO THE STANDBY VALVE IN ORDER TO RESOLVE THE REPORTED LEAKAGE. THERE IS NO INFORMATION IF ANY PARTS HAVE BEEN REPLACED. THE MOST PROBABLE CAUSE TO THIS FAILURE WAS LEAKAGE IN THE FITTINGS OF THE STANDBY VALVE, BUT THE TRUE ROOT CAUSE CANNOT BE DETERMINED WITHOUT INVESTIGATING THE FITTINGS THEMSELVES. GETINGE USA SALES, LLC (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF MAQUET CRITICAL CARE AB (MANUFACTURER). REF. EXEMPTION #: E2018003. GETINGE USA SALES, LLC (B)(4). CONTACT PERSON: (B)(4).

    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

    IMPORTER REF. #: (B)(4). MANUFACTURER REF. #: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS AN AIR LEAKAGE IN THE COMPRESSOR. THERE WAS NO PATIENT INVOLVEMENT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    912482 COMPRESSOR MINI COMPRESSOR, AIR, PORTABLE BTI MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1