BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-U

    MDR report key: 8783850 · Received July 12, 2019

    Report

    Report Number
    8010042-2019-00493
    Event Type
    Malfunction
    Date Received
    July 12, 2019
    Date of Event
    June 20, 2019
    Report Date
    January 10, 2020
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K180098
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    THE VENTILATOR WAS NOT INVESTIGATED BY OUR FIELD SERVICE ENGINEER SINCE THE USER FACILITY PERFORMS REPAIR AND SERVICE BY THEMSELVES AND DID NOT REQUEST ANY SERVICE. THE BIOMED TESTED THE VENTILATOR AND COULD NOT DUPLICATE THE REPORTED ISSUE. NO VENTILATOR LOGS WERE PROVIDED. SINCE THE VENTILATOR PASSED FUNCTIONAL TESTS AND NO LOGS OR PARTS WERE RETURNED FOR INVESTIGATION, THE ROOT CAUSE OF THE REPORTED EVENT HAS NOT BEEN DETERMINED.

    Description of Event or Problem · 0

    MANUFACTURER'S REF # : 221417.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PATIENT TREATMENT, THE DELIVERED RESPIRATORY RATE DIFFERED FROM THE SET VALUE. THERE WAS NO PATIENT HARM. MANUFACTURER'S REF.: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    580481 SERVO-U VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB SERVO-U

    Patients

    Seq Age Sex Outcome Treatment
    1