BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-U

    MDR report key: 8979350 · Received September 10, 2019

    Report

    Report Number
    8010042-2019-00671
    Event Type
    Malfunction
    Date Received
    September 10, 2019
    Date of Event
    August 18, 2019
    Report Date
    April 24, 2020
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K180098
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    OUR FIELD SERVICE ENGINEER REVIEWED THE DEVICE LOGS AND CONFIRMED THE HIGH AIRWAY PRESSURE ALARM. THE DEVICE FAILED THE PATIENT CIRCUIT TEST DURING PRE-USE CHECK. HE FOUND THAT THE DEVICE HAD NOT HAD A PREVENTIVE MAINTENANCE PERFORMED SINCE 2017 AND INSTALLED A CUSTOMER PROVIDED 5000 HOURS MAINTENANCE KIT WHICH INCLUDE GAS MODULE NOZZLES. HE INSTALLED A NEW INSPIRATORY PIPE AND TUBE. AFTER THAT PRE-USE CHECK TESTS PASSED. NO PART WAS RETURNED. THE EVALUATION OF THE RECEIVED DEVICE LOGS CONFIRMS HIGH AIRWAY PRESSURE ONE DAY BEFORE THE REPORTED DATE OF EVENT, BUT ALSO ON OCCASIONS BEFORE THAT. FOR EXAMPLE A MALFUNCTIONING GAS MODULE NOZZLE UNIT MAY LEAD TO HIGH PRESSURE, BUT THIS COULD NOT BE CONFIRMED. ALARMS FOR HIGH PRESSURE WILL BE GENERATED. THE CONCLUSION IN THIS MATTER IS THAT THE REPORTED PROBLEM WITH GENERATED ALARMS FOR HIGH AIRWAY PRESSURE WAS RESOLVED BY THE MAINTENANCE KIT AND REPLACED PARTS. AS NO PART WAS RETURNED FOR INVESTIGATION, THE ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    MANUFACTURER'S REF #: 240685.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTILATOR GENERATED ALARMS FOR HIGH AIRWAY PRESSURE. THERE WAS NO PATIENT HARM. MANUFACTURER'S REF #: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    774099 SERVO-U VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB SERVO-U

    Patients

    Seq Age Sex Outcome Treatment
    1