BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-U

    MDR report key: 8564691 · Received April 30, 2019

    Report

    Report Number
    8010042-2019-00288
    Event Type
    Malfunction
    Date Received
    April 30, 2019
    Report Date
    September 25, 2019
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K180098
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED ISSUE WAS INVESTIGATED AT THE HOSPITAL BY OUR FIELD SERVICE ENGINEER (FSE). THE ISSUE COULD BE CONFIRMED, THE HUMIDIFIER/IV POLE HOLDER WAS LOOSE AND LEANING AWAY FROM THE MACHINE. NO PARTS HAVE BEEN SENT IN FOR INVESTIGATION. A SET SCREW HOLDS THE ALUMINUM PIECE TO THE SUPPORT ARM, THE SET SCREWS WERE STRIPPED OUT. THE ISSUE WAS RESOLVED BY REPLACING THE SCREWS AND SECURING THE POSITION OF THE HOLDER. A DESIGN IMPROVEMENT WAS IMPLEMENTED DURING (B)(6)2018 AND AN ADDITIONAL SET SCREW HAS BEEN INTRODUCED. OUR CONCLUSION INTO THIS MATTER IS THAT THE HUMIDIFIER HOLDER MOST LIKELY HAS BEEN EXPOSED TO A WEIGHT THAT IS GREATER THAN IT IS DESIGNED TO SUSTAIN.

    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 PERON: (B)(4).

    Description of Event or Problem · 0

    MANUFACTURER REFERENCE#:1915MCC1613. IMPORTER REFERENCE #:(B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SUPPORT ARM WAS COMING LOOSE AND WAS CAUSING THE ALUMINUM PIECE THAT CONNECTS TO THE SUPPORT RAIL, TO PULL AWAY. THERE WAS NO PATIENT INVOLVEMENT. MANUFACTURER REFERENCE#: (B)(4). IMPORTER REFERENCE #: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357777 SERVO-U VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1