BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPRESSOR MINI 115V 60HZ

    MDR report key: 18045233 · Received November 1, 2023

    Report

    Report Number
    8010042-2023-02108
    Event Type
    Malfunction
    Date Received
    November 1, 2023
    Report Date
    November 1, 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

    ON-SITE INVESTIGATION WAS PERFORMED. ACCORDING TO TECHNICIAN STATEMENT, THE DRAINAGE VALVE WAS FOUND DEFECTIVE AND REPLACED. THE ISSUE HAS BEEN RESOLVED AND THE DEVICE WAS DELIVERED TO THE USER IN WORKING CONDITION. THE ISSUE WAS REPORTED TO COMPETENT AUTHORITY IN ABUNDANCE OF CAUTION AS IT MAY IN SOME CASES, REPRESENT A REPORTABLE EVENT. FURTHER EVALUATION OF THE ISSUE INDICATED, THAT SERVO VENTILATOR OR FLOW ANESTHESIA WORKSTATION SWITCHES TO 100% OXYGEN WHEN LOOSING AIR INLET PRESSURE. ALARMS WILL BE GENERATED, AND PROPER MEASURES CAN BE TAKEN. THERE IS NO INDICATION THAT THE COMPRESSOR DELIVERED COMPRESSED AIR TO THE VENTILATOR WITH A RELATIVE HUMIDITY THAT EXCEEDED THE SPECIFICATION. THE DRAINAGE VALVE IS POWERED WITH 12 V AND ELECTRICALLY CONTROLLED BY THE PRINTED CIRCUIT (PC) BOARD. THE PURPOSE OF THE DRAINAGE VALVE IS TO REMOVE WATER COLLECTED IN THE WATER SEPARATOR AT REGULAR INTERVALS. THE VALVE IS CLOSED IN NON-ACTIVATED CONDITION. DURING OPERATION, THE VALVE WILL BE ACTIVATED (OPEN) FOR APPROX. 0.5 SECONDS TWICE EVERY MINUTE BY THE TIMING CIRCUIT ON THE PC BOARD. THE CLAIMED PART HAS BEEN NOT AVAILABLE FOR THE FURTHER ANALYZE OF THE ISSUE. THEREFORE, THE ROOT CAUSE TO THE REPORTED ISSUE HAS NOT BEEN DETERMINED.

    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 # AND H4 DEVICE MANUFACTURE DATE, CORRESPOND TO DEVICE INVOLVED IN THE EVENT, WHICH IS "COMPRESSOR MINI 230V¿. A CORRECTION OF FIELDS # D1 BRAND NAME, # D4 VERSION OR MODEL # AND # D4 UNIQUE IDENTIFIER (UDI) # 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. D4 ¿ UNIQUE IDENTIFIER (UDI) # - PREVIOUS UNIQUE IDENTIFIER (UDI) #: (B)(6). CORRECTED PRIMARY DI NUMBER: (B)(6).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WATER WAS COMING FROM THE AIR OUTLET THERE WAS NO PATIENT HARM. MANUFACTURER'S REF #: 918078.

    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
    2092518 COMPRESSOR MINI 115V 60HZ COMPRESSOR, AIR, PORTABLE BTI MAQUET CRITICAL CARE AB 6481779 07325710001653

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown