BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-I

    MDR report key: 4152410 · Received October 3, 2014

    Report

    Report Number
    8010042-2014-00455
    Event Type
    Malfunction
    Date Received
    October 3, 2014
    Date of Event
    September 26, 2014
    Report Date
    September 30, 2014
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K123149
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MORE INFO SURROUNDING THE EVENT HAS BEEN SOUGHT. A SUPPLEMENTAL MEDWATCH WILL BE PROVIDED WHEN INVESTIGATION IS FINISHED. (B)(4).

    Additional Manufacturer Narrative · 1

    THE VENTILATOR OPERATES IN A FIELD OF UP TO 20MT (200 GAUSS) FOR TUNNEL SCANNERS AND UP TO 10MT (100 GAUSS) FOR OPEN SCANNERS. BEFORE USING THE VENTILATOR IN THE MR ENVIRONMENT, CONDITIONS MUST BE MET, INCLUDING LOCKING THE TWO FRONT WHEELS AND PLACING THE VENTILATOR OUTSIDE THE 200 GAUSS (20MT) SAFETY LINE, WHICH MUST BE MARKED AROUND THE MR SCANNER. THESE CONDITIONS ARE STATED IN THE DECLARATION FOR THE USE OF THE VENTILATOR IN THE MR ENVIRONMENT, AND ARE INCLUDED AS PART OF THE "MR ENVIRONMENT AGREEMENT," WHICH WAS SIGNED BY THE HOSPITAL. ACCORDING TO RECEIVED INFORMATION, THE WHEELS OF THE VENTILATOR WERE RIOT LOCKED AT THE TIME OF THE EVENT. THE VENTILATOR WAS INVESTIGATED ON-SITE BY OUR FIELD SERVICE ENGINEER. IT WAS FOUND TO BE DAMAGED AS A CONSEQUENCE OF THE MR EVENT, AND WAS NOT FUNCTIONING. VISUAL INSPECTION OF RECEIVED PHOTOS CONFIRMS THAT THE VENTILATOR HAD RECEIVED DAMAGES AFTER THE EVENT. OUR CONCLUSION IS THAT THE USER DID NOT FOLLOW THE CONDITIONS FOR USE OF THE VENTILATOR IN THE MR ENVIRONMENT. THE VENTILATOR'S TWO FRONT WHEELS WERE UNLOCKED AND IT WAS THEREFORE ATTRACTED TO THE MR SCANNER AS A RESULT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTILATOR WAS PULLED INTO THE MRI SCANNER. THERE WAS NO PT INVOLVEMENT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    617528 SERVO-I CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1