BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPRESSOR MINI

    MDR report key: 11299897 · Received February 9, 2021

    Report

    Report Number
    8010042-2021-00296
    Event Type
    Malfunction
    Date Received
    February 9, 2021
    Report Date
    March 12, 2021
    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

    THE REPORTED VENTILATOR WAS REPAIRED ON SITE BY UNKNOWN PERSONNEL WITH THE GUIDANCE FROM FSE OVER TELEPHONE. IT IS UNKNOWN HOW THE AIR CONNECTION NIPPLE BECAME LOOSE. FASTENING OF THE NIPPLE IS PERFORMED WITH TORQUE WRENCH FROM THE MANUFACTURER. THE MANUFACTURER HAS NO RESPONSIBILITY FOR THE SAFE OPERATION OF THE SYSTEM IF INSTALLATION, SERVICE OR REPAIRS ARE PERFORMED BY PERSONS OTHER THAN THOSE AUTHORIZED BY THE MANUFACTURER. GENERAL SAFETY GUIDELINES: DO NOT MODIFY OR REMOVE ANY ORIGINAL PARTS.     ONLY ACCESSORIES, SUPPLIES, AND AUXILIARY EQUIPMENT RECOMMENDED BY THE MANUFACTURER SHOULD BE USED WITH THE SYSTEM. USE OF ANY OTHER ACCESSORIES, SPARE PARTS OR AUXILIARY EQUIPMENT MAY CAUSE DEGRADED SYSTEM PERFORMANCE AND SAFETY.         SERVICE, REPAIR AND INSTALLATION MUST ONLY BE PERFORMED BY PERSONNEL AUTHORIZED BY THE MANUFACTURER. A LEAKAGE IN THE COMPRESSOR AIR OUTLET COULD LEAD TO THE LOSS OF AIR SUPPLY FOR A CONNECTED VENTILATOR. THIS COULD, DEPENDING ON OXYGEN LEVEL BEING USED, RESULT IN STOP OF VENTILATION OR IN A LOWER THAN SET PRESSURE IN THE PATIENT CIRCUIT. A LOW PRESSURE ALARM WILL BE TRIGGERED IF THIS ERROR OCCURS. NO ROOT CAUSE CAN BE DETERMINED DUE TO LACK OF INFORMATION. H3 OTHER TEXT : GUIDANCE FROM MFG GIVEN OVER TELEPHONE.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE COMPRESSOR ALARMED FOR LOW PRESSURE. THERE WAS NO PATIENT HARM. MANUFACTURER'S REF #: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    198585 COMPRESSOR MINI COMPRESSOR, AIR, PORTABLE BTI MAQUET CRITICAL CARE AB COMPR MINI 230V 50HZ

    Patients

    Seq Age Sex Outcome Treatment
    1