BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPRESSOR MINI

    MDR report key: 17057997 · Received June 5, 2023

    Report

    Report Number
    8010042-2023-01060
    Event Type
    Malfunction
    Date Received
    June 5, 2023
    Report Date
    June 5, 2023
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    BTI
    UDI-DI
    07325710001523
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE CLAIMED ISSUE WAS RELATED TO LOW PRESSURE ALARM. THERE WAS NO PATIENT HARM. IDENTIFICATION OF ISSUE HAS BEEN DONE BY ANALYZING PROBLEM DESCRIPTION. THE ISSUE WAS REPORTABLE DUE TO THE FACT THAT IT MAY LEAD TO STOP OF VENTILATION. THE ISSUE WAS RESOLVED BY THE CUSTOMER BY REPLACING COMPRESSOR TUBING KIT. THE DEVICE WAS RETURNED TO USAGE IN WORKING CONDITION. THE ROOT CAUSE OF THE ISSUE HAS NOT BEEN DETERMINED. THE CORRECTION OF FIELD #H8 USAGE OF DEVICE WAS REQUIRED. THIS IS BASED ON THE INTERNAL EVALUATION. #H8 USAGE OF DEVICE: PREVIOUS USAGE OF DEVICE: UNKNOWN. CORRECTED USAGE OF DEVICE: REUSE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE COMPRESSOR ALARMED FOR LOW PRESSURE. THERE WAS NO PATIENT HARM. MANUFACTURER'S REF. #: 832273

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1410514 COMPRESSOR MINI COMPRESSOR, AIR, PORTABLE BTI MAQUET CRITICAL CARE AB COMPR MINI 230V 50HZ 07325710001523

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown