BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-U

    MDR report key: 8699187 · Received June 14, 2019

    Report

    Report Number
    8010042-2019-00399
    Event Type
    Malfunction
    Date Received
    June 14, 2019
    Date of Event
    May 22, 2019
    Report Date
    September 6, 2019
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K18009
    Report Source
    Manufacturer report
    Reporter Location
    WI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    NO SERVICE ON THE VENTILATOR HAS BEEN REQUESTED BY THE USER FACILITY. EVALUATION OF PROVIDED VENTILATOR LOGS FOUND THAT ON THE REPORTED EVENT DATE AND TIME, THERE ARE SEVERAL LOG POSTS THAT DISCONNECTION/SUCTION PROGRAM WAS STARTED BUT NO ALARMS FOR LOW O2 CONCENTRATION WERE GENERATED. THE LOW O2 CONCENTRATION ALARMS ARE GENERATED WHEN THE O2 CONCENTRATION BECOMES LOWER THAN THE LOWER ALARM LIMIT WHICH IS SET VALUE -5 VOL%. THE TECHNICAL LOG DOES NOT CONTAIN ANY TECHNICAL ERROR CODES TO INDICATE THAT THERE WAS A VENTILATOR MALFUNCTION AT THE TIME OF THE EVENT. THE VENTILATOR PASSED PRE-USE CHECK 8 DAYS PRIOR THE REPORTED EVENT DATE. THE ROOT CAUSE OF THE REPORTED LOW O2 CONCENTRATION COULD NOT BE DETERMINED. H3 OTHER TEXT : 4114.

    Additional Manufacturer Narrative · 0

    GETINGE USA SALES, LLC (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF: MAQUET CRITICAL CARE AB (MANUFACTURER). REF. EXEMPTION : E2018003. GETINGE USA SALES, LLC, 45 BARBOUR POND DRIVE, WAYNE, NJ 07470. CONTACT PERSON: (B)(4).

    Description of Event or Problem · 0

    MANUFACTURER'S REF #: 213615.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING PATIENT TREATMENT, THE DELIVERED O2 CONCENTRATION WAS NOT AS SET VALUE. THERE WAS NO PATIENT HARM. MANUFACTURER'S REF #: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    492399 SERVO-U VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1