BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPRESSOR MINI

    MDR report key: 7961321 · Received October 12, 2018

    Report

    Report Number
    8010042-2018-00544
    Event Type
    Malfunction
    Date Received
    October 12, 2018
    Date of Event
    October 2, 2018
    Report Date
    October 31, 2018
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    BTI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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).

    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 (B)(4). CONTACT PERON: (B)(4). OUR INVESTIGATION OF THE COMPLAINT IS FINALIZED. INVESTIGATION ON SITE HAS BEEN PERFORMED BY OUR FIELD SERVICE ENGINEER (FSE). THE FSE REPLACED THE FAULTY MAINS INLET. THE UNIT PASSED ALL FUNCTIONAL AND SAFETY TESTS PER FACTORY SPECIFICATIONS, RETURNED TO CUSTOMER AND CLEARED FOR CLINICAL USE. NO PICTURES OR PARTS WERE RECEIVED FOR THIS COMPLAINT TO SUPPORT THE FAILURE CONDITION. SIMILAR EARLIER INVESTIGATIONS DETERMINED THAT THE CAUSE COULD BE ONE OR A COMBINATION OF THE FOLLOWING CAUSES: 1. HIGH VOLTAGE (HIGHER THAN THE MAINS INLET IS SPECIFIED FOR I.E. > 127 V) MAKES THE CURRENT AND TEMPERATURE INCREASES IN THE FUSE AND ACCELERATES THE AGEING. 2. DUSTY ENVIRONMENT MAY INCREASE THE TEMPERATURE AROUND THE FUSE AND MAY AFFECT THE CONTACT BETWEEN FUSE AND FUSE HOLDER WHEN THE TEMPERATURE IS INCREASING. (THE DUST FILTER MUST BE REPLACED DURING PREVENTIVE.) 3. VIBRATIONS MAY INCREASE THE CONTACT PROBLEM IN THE FUSE HOLDER. 4. CHEMICALS IN THE AIR OR BY CLEANING MAY CAUSE CONTACT PROBLEM BETWEEN FUSE AND BOTTOM CONTACT. CHEMICAL INVESTIGATION AT KTH FOUND RESIDUALS FROM SOME CLEANING SOLUTIONS AT THE BOTTOM CONTACT. WE HAVE NOT BEEN ABLE TO DETERMINE THE TRUE CAUSE OF THE EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE COMPRESSOR WILL NOT START UP. THERE WAS NO PATIENT INVOLVEMENT. (B)(4).

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    803788 COMPRESSOR MINI COMPRESSOR, AIR, PORTABLE BTI MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1