BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-I

    MDR report key: 9150081 · Received October 3, 2019

    Report

    Report Number
    8010042-2019-00724
    Event Type
    Malfunction
    Date Received
    October 3, 2019
    Date of Event
    September 18, 2019
    Report Date
    March 27, 2020
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K123149
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    WHILE PERFORMING PREVENTIVE MAINTENANCE, THE VENTILATOR FAILED PRESSURE TRANSDUCER TEST DURING PRE-USE CHECK. THE FIELD SERVICE ENGINEER REPLACED THE PRESSURE TRANSDUCER PC (PRINTED CIRCUIT) BOARD. THE PC BOARD WAS NOT RETURNED FOR INVESTIGATION. NO VENTILATOR LOGS WERE PROVIDED. SINCE NO PARTS WERE RETURNED FOR INVESTIGATION, THE ROOT CAUSE OF THE FAILED PRESSURE TRANSDUCER TEST HAS NOT BEEN DETERMINED.

    Description of Event or Problem · 0

    MANUFACTURER'S REF #: 253507.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTILATOR FAILED PRESSURE TRANSDUCER TEST DURING PRE-USE CHECK. THERE WAS NO PATIENT INVOLVEMENT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    945613 SERVO-I VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB SERVO-I

    Patients

    Seq Age Sex Outcome Treatment
    1