BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPRESSOR MINI 115V 60HZ

    MDR report key: 18028284 · Received October 30, 2023

    Report

    Report Number
    8010042-2023-02083
    Event Type
    Malfunction
    Date Received
    October 30, 2023
    Date of Event
    October 8, 2023
    Report Date
    October 30, 2023
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    BTI
    UDI-DI
    07325710001653
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    **UDI RELATED DATA QUALITY UPDATES ** THIS EVENT OCCURRED ON THE INDIAN MARKET ON A SIGNIFICANTLY SIMILAR DEVICE TO ¿COMPRESSOR MINI 115V 60HZ¿ WHICH IS SOLD IN THE US. THEREFORE, FOR D4 UNIQUE IDENTIFIER (UDI) #, PRIMARY DI NUMBER HAS BEEN USED FROM COMPRESSOR MINI 115V 60HZ. PROVIDED IN INITIAL REPORT: D4 SERIAL #, CORRESPONDS TO DEVICE INVOLVED IN THE EVENT, WHICH IS "COMPRESSOR MINI 230V¿. A CORRECTION OF FIELDS # D1 BRAND NAME AND # D4 VERSION OR MODEL # WERE REQUIRED. D1 ¿ BRAND NAME ¿ PREVIOUS BRAND NAME: COMPRESSOR MINI. CORRECTED BRAND NAME: COMPRESSOR MINI 115V 60HZ D4 ¿ VERSION OR MODEL # - PREVIOUS VERSION OR MODEL #: COMPR MINI 230V 50HZ. CORRECTED VERSION OR MODEL #: 6481779

    Additional Manufacturer Narrative · 0

    THE REPORTED ISSUE HAS BEEN CONFIRMED DURING EVALUATION OF THE RECEIVED PROBLEM DESCRIPTION. SERVICE REPORT AND DEVICE'S LOG FILES WERE NOT PROVIDED. NO FURTHER INFORMATION IS AVAILABLE. H3 OTHER TEXT : 4119.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE COMPRESSOR DID NOT START. THERE WAS NO PATIENT HARM REPORTED. MANUFACTURER'S REF. #: 905582.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1889700 COMPRESSOR MINI 115V 60HZ COMPRESSOR, AIR, PORTABLE BTI MAQUET CRITICAL CARE AB 6481779 07325710001653

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown