BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-I

    MDR report key: 8478059 · Received April 3, 2019

    Report

    Report Number
    8010042-2019-00230
    Event Type
    Malfunction
    Date Received
    April 3, 2019
    Date of Event
    March 26, 2019
    Report Date
    September 12, 2019
    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

    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).

    Additional Manufacturer Narrative · 0

    THE REPORTED DEVICE WAS INVESTIGATED AT THE HOSPITAL BY OUR FIELD SERVICE ENGINEER. THE ISSUE WAS RESOLVED BY REPLACING THE VERIFIED BROKEN WHEELS. VISUAL INSPECTION OF THE RECEIVED PHOTOGRAPHS OF THE DEVICE WHEEL SHOWS CLEAR SIGNS OF WEAR AND TEAR. THE BROKEN WHEEL IMPLIES THAT THE UNIT HAS BEEN EXPOSED TO A MECHANICAL FORCE THAT'S ABOVE THE DESIGNED SPECIFICATION. THE VENTILATOR SYSTEM HAS BEEN SUCCESSFULLY TESTED FOR MECHANICAL STRENGTH, WITH A PEAK ACCELERATION OF 15G, PULSE DURATION 6MS, AND TOTAL NUMBER OF 1000 IMPACTS. IT¿S UNKNOWN TO US UNDER WHICH CONDITIONS THE REPORTED WHEEL BROKE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE WHEEL ON THE VENTILATOR BROKE. THERE WAS NO PATIENT INVOLVEMENT. (B)(4).

    Description of Event or Problem · 0

    IMPORTER REF. #: (B)(4). MANUFACTURER REF. #: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273564 SERVO-I VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1