BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPRESSOR MINI

    MDR report key: 8115057 · Received November 29, 2018

    Report

    Report Number
    8010042-2018-00639
    Event Type
    Malfunction
    Date Received
    November 29, 2018
    Report Date
    April 24, 2019
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    BTI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    MAQUET MEDICAL SYSTEMS,USA(IMPORTER)SUBMITS THIS REPORT ON BEHALF OF THE LEGAL MANUFACTURER OF THE DEVICE MAQUET CARDIOPULMONARY AG KEHLER STRASSE 31, 76437 RASTATT, GERMANY. A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. REFERENCE EXEMPTION #(B)(4). IMPORTER- MAQUET MEDICAL SYSTEMS USA (B)(4). CONTACT PERSON- (B)(6). THE DEVICE WAS INVESTIGATED BY THE DISTRIBUTOR AND THE COMPRESSOR MOTOR WAS REPLACED AND RETURNED FOR INVESTIGATION. OUR INVESTIGATION OF THE COMPRESSOR MOTOR DID NOT SHOW ANY ERRORS, THE MOTOR FUNCTION WAS ACCORDING SPECIFICATION. THE INVESTIGATION FINDINGS DO NOT LEAD TO A CLEAR CONCLUSION ABOUT THE CAUSE OF THE REPORTED EVENT.

    Additional Manufacturer Narrative · 0

    (B)(4). REFERENCE EXEMPTION # E2018002. A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE COMPRESSOR ALARMED FOR LOW PRESSURE. PATIENT INVOLVEMENT IS UNKNOWN. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    954116 COMPRESSOR MINI COMPRESSOR, AIR, PORTABLE BTI MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1