BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BASE UNIT SERVO-U

    MDR report key: 18959375 · Received March 22, 2024

    Report

    Report Number
    8010042-2024-00513
    Event Type
    Malfunction
    Date Received
    March 22, 2024
    Date of Event
    March 10, 2024
    Report Date
    March 22, 2024
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    UDI-DI
    07325710001110
    PMA / PMN Number
    K201874
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO SERVICE ON THE VENTILATOR HAS BEEN REQUESTED BY THE HOSPITAL. THE INVESTIGATION WAS MADE BASED ON THE RECEIVED LOGS AND PROVIDED INFORMATION. THE RECEIVED LOGS REVEALED CLINICAL ALARMS AT DATE OF THE EVENT SUCH AS: LOW EXPIRATORY MINUTE VOLUME ALARM, PATIENT CIRCUIT DISCONNECTED, PRESSURE DELIVERY RESTRICTED, PEEP LOW AND RESPIRATORY RATE HIGH WHICH. THESE CLINICAL ALARMS INDICATES LEAKAGE IN THE PATIENT BREATHING CIRCUIT OR A DISCONNECT SITUATION. THE TEST LOG SHOWS A SUCCESSFUL PRE-USE CHECK PRIOR TO THE DATE OF EVENT. THERE IS NO INDICATION OF A TECHNICAL MALFUNCTION IN THE SYSTEM AT THE TIME OF THE EVENT. THERE IS NO INFORMATION WHETHER ANY PARTS HAVE BEEN REPLACED. THEREFORE, THE ROOT CAUSE OF THE GENERATED ALARMS HAS NOT BEEN DETERMINED. A CORRECTION OF FIELD # D1 BRAND NAME, # D4 VERSION OR MODEL # WERE REQUIRED. D1 ¿ BRAND NAME - PREVIOUS BRAND NAME: SERVO-U, CORRECTED BRAND NAME: BASE UNIT SERVO-U, D4 ¿ VERSION OR MODEL # - PREVIOUS VERSION OR MODEL #: SERVO-U, CORRECTED VERSION OR MODEL #: 6694800.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE VENTILATOR GENERATED ALARMS INDICATING LOW EXPIRATORY MINUTE VOLUME. THERE WAS NO PATIENT HARM. MANUFACTURER'S REF. #: (B)(4).

    Description of Event or Problem · 0

    MANUFACTURER'S REF: # 1000295.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2342457 BASE UNIT SERVO-U VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB 6694800 07325710001110

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown