BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-S

    MDR report key: 8948693 · Received August 30, 2019

    Report

    Report Number
    8010042-2019-00643
    Event Type
    Malfunction
    Date Received
    August 30, 2019
    Report Date
    March 17, 2020
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K123149
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE VENTILATOR WAS INVESTIGATED BY OUR FIELD SERVICE ENGINEER (FSE). THE AIR GAS MODULE WAS FOUND TO BE CONTAMINATED BY WATER. THE AIR GAS MODULE WAS REPLACED BUT NOT RETURNED FOR INVESTIGATION. NO VENTILATOR LOGS WERE PROVIDED.THE ROOT CAUSE OF THE FAILED PRE-USE CHECK IS THE WATER CONTAMINATION OF THE AIR GAS MODULE. HOW THE WATER ENTERED HAS NOT BEEN DETERMINED BUT MOST LIKELY THE COMPRESSED AIR CONTAINED HUMIDITY OUT OF TOLERANCE.

    Description of Event or Problem · 0

    MANUFACTURER'S REF #: 241424.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    742194 SERVO-S VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB SERVO-S

    Patients

    Seq Age Sex Outcome Treatment
    1