BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPRESSOR MINI

    MDR report key: 8820652 · Received July 24, 2019

    Report

    Report Number
    8010042-2019-00532
    Event Type
    Malfunction
    Date Received
    July 24, 2019
    Date of Event
    January 27, 2019
    Report Date
    February 20, 2020
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    BTI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT THE PRESSURE WENT HIGH WHILE THE COMPRESSOR WAS CONNECTED TO A VENTILATOR FOR AIR SUPPLY TO A PATIENT. THERE WAS NO PATIENT HARM REPORTED. AFTER CHECKING, THE COMPRESSOR¿S MOTHERBOARD WAS FOUND FAULTY AND IT WAS RECOMMENDED TO REPLACE IT. THE USER CONTRACTED A THIRD-PARTY REPAIR COMPANY FOR THE SERVICE WHY NO PART WAS RETURNED AND DEVICE LOGS WERE NOT RECEIVED. REPORTED INFORMATION AND SYMPTOMS SUGGEST THAT THE PRESSURE SUPERVISION ON THE PRINTED CIRCUIT BOARD ASSEMBLY WAS FALSELY ALARMING FOR HIGH PRESSURE MEASURED INSIDE THE COMPRESSED AIR TANK. IF THIS HAPPENS THE ACTUAL DELIVERED AIR PRESSURE FROM THE COMPRESSOR MINI IS NOT AFFECTED. HOWEVER, WHEN THIS FAULT CONDITION OCCURS THE COMPRESSOR MAY PUT ITSELF INTO STANDBY MODE WHICH MEANS THAT AIR DELIVERY WILL STOP. IF THE COMPRESSOR IS USED AS BACK-UP AIR SUPPLY AND THE INDICATED FAULT CONDITION OCCURS, THE COMPRESSOR MIGHT FAIL TO DELIVER AIR. THE VENTILATOR WILL SWITCH TO PURE OXYGEN DELIVERY IF THE AIR SUPPLY FAILS AND ALARMS FOR HIGH OXYGEN CONCENTRATION WILL BE GENERATED. IF NO OXYGEN IS CONNECTED TO THE VENTILATOR, VENTILATION WILL STOP AS A WORST CASE SCENARIO. ALARMS WILL BE GENERATED. THE CONCLUSION IN THIS MATTER IS THAT THE COMPRESSOR PROBABLY ALARMED FALSE FOR HIGH PRESSURE. AS NO GOODS WERE RETURNED FOR INVESTIGATION, THIS COULD NOT BE CONFIRMED AND THE CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED. H3 OTHER TEXT : 4114

    Description of Event or Problem · 0

    MANUFACTURER REFERENCE #: 231398.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PRESSURE WAS HIGH WHILE THE COMPRESSOR WAS CONNECTED TO A VENTILATOR FOR THE SUPPLY OF AIR GAS TO THE PATIENT. THERE WAS NO PATIENT HARM. MANUFACTURER REFERENCE #: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    615687 COMPRESSOR MINI COMPRESSOR, AIR, PORTABLE BTI MAQUET CRITICAL CARE AB COMPR MINI 230V 50HZ

    Patients

    Seq Age Sex Outcome Treatment
    1