BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPRESSOR MINI

    MDR report key: 8949101 · Received August 30, 2019

    Report

    Report Number
    8010042-2019-00642
    Event Type
    Malfunction
    Date Received
    August 30, 2019
    Report Date
    May 11, 2020
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    BTI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT THE COMPRESSOR WAS SHUTTING OFF AND ON. OUR FIELD SERVICE ENGINEER VERIFIED THAT THE COMPRESSOR WAS GOING INTO STANDBY MODE PREMATURELY. AFTER THE STANDBY VALVE WAS REPLACED THE COMPRESSOR PASSED ALL FUNCTIONAL AND SAFETY TEST PER FACTORY SPECIFICATIONS AND WAS RETURNED TO CUSTOMER AND CLEARED FOR CLINICAL USE. NO PART WAS RETURNED. A COMPRESSOR THAT REPEATEDLY GOES TO STANDBY MAY NOT DELIVER ENOUGH AIR TO THE CONNECTED VENTILATOR. IF THIS OCCURS, ALARMS FOR LOW AIR SUPPLY PRESSURE AND HIGH O2 CONCENTRATION MAY APPEAR DEPENDING ON THE COMPRESSORS RUN/STANDBY DUTY CYCLE. IF NO O2 GAS IS CONNECTED TO THE VENTILATOR, STOP OF VENTILATION MAY RESULT AS A WORST CASE SCENARIO. THE CONCLUSION IN THIS MATTER IS THAT THE STANDBY VALVE WAS DEFECTIVE. AS NO GOODS WERE RETURNED FOR INVESTIGATION, THE ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    MANUFACTURER'S REF : 241639.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE COMPRESSOR WAS SHUTTING OFF AND ON. THERE WAS NO PATIENT HARM. MANUFACTURER'S REF: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    743840 COMPRESSOR MINI COMPRESSOR, AIR, PORTABLE BTI MAQUET CRITICAL CARE AB COMPR MINI 115V 60HZ

    Patients

    Seq Age Sex Outcome Treatment
    1