BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-U

    MDR report key: 9937320 · Received April 8, 2020

    Report

    Report Number
    8010042-2020-00201
    Event Type
    Malfunction
    Date Received
    April 8, 2020
    Date of Event
    March 31, 2020
    Report Date
    February 1, 2021
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K180098
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT THE DISS AIR FILTER (WATER TRAP) THAT IS CONNECTED BETWEEN THE VENTILATOR THE COMPRESSED AIR SOURCE WAS BROKEN. A VISUAL INSPECTION OF THE RETURNED AIR FILTER DID NOT SHOW ANY ANOMALIES. THE DISS AIR FILTER WAS MOUNTED BETWEEN THE REFERENCE COMPRESSOR AND THE REFERENCE VENTILATOR. THE FILTER DIDN¿T LEAK. SIX DAYS OF SIMULATED USE TEST VENTILATION WITH COMPRESSED AIR VIA THE AIR FILTER PASSED WITHOUT ANY DEFICIENCY NOTED. A BROKEN WALL MOUNT BRACKET WAS CONNECTED TO THE AIR FILTER UPON RETURN. THIS BRACKET IS NOT A MAQUET PRODUCT AND IS THEREFORE NOT THE SUBJECT OF THIS INVESTIGATION. THE BRACKET MANUFACTURER, ALLIED HEALTHCARE PRODUCTS INC., HAS BEEN INFORMED. THE CONCLUSION IN THIS MATTER IS THAT THE RETURNED DISS AIR FILTER WORKED WITHOUT ISSUES DURING THE INVESTIGATION. NO FILTER MALFUNCTION WAS FOUND.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE WATER TRAP (AIR FILTER) THAT IS CONNECTED BETWEEN THE VENTILATOR AND THE AIR COMPRESSOR WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT. MANUFACTURER'S REF #: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403611 SERVO-U VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB SERVO-U

    Patients

    Seq Age Sex Outcome Treatment
    1