BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPRESSOR MINI

    MDR report key: 8527009 · Received April 18, 2019

    Report

    Report Number
    8010042-2019-00273
    Event Type
    Malfunction
    Date Received
    April 18, 2019
    Report Date
    September 23, 2019
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    BTI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION OF THE RETURNED COMPRESSOR PCB (PRINTED CIRCUIT BOARD) AND DRAINAGE VALVE DID NOT GENERATE ANY ERRORS. THE DEVICE LOGS FROM THE CONNECTED VENTILATOR UNIT WERE NOT RETURNED, THE REPORTED STANDBY ISSUE CANNOT BE VERIFIED BY THE LOGS. THE SIMULATED TESTS PERFORMED IN A TEST COMPRESSOR WITH THE RETURNED PARTS INSTALLED, DID NOT SHOW ANY DEVIATIONS, THE PARTS WERE WORKING ACCORDING TO SPECIFICATIONS. INVESTIGATION FINDINGS DO NOT LEAD TO A CLEAR CONCLUSION ABOUT THE CAUSE OF THE REPORTED EVENT.

    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 PERON: (B)(4).

    Description of Event or Problem · 0

    IMPORTER REF. #:(B)(4). MANUFACTURER REF. #: 1915MCC1597.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE COMPRESSOR DID NOT TURN ON DURING PATIENT TREATMENT. THERE WAS NO PATIENT HARM. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319245 COMPRESSOR MINI COMPRESSOR, AIR, PORTABLE BTI MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1