BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-I

    MDR report key: 3980206 · Received July 2, 2014

    Report

    Report Number
    8010042-2014-00289
    Event Type
    Malfunction
    Date Received
    July 2, 2014
    Date of Event
    June 6, 2014
    Report Date
    June 6, 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
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MORE INFO HAS BEEN REQUESTED FOR INVESTIGATION. A SUPPLEMENTAL MEDWATCH WILL BE PROVIDED WHEN THE INVESTIGATION HAS BEEN FINALIZED. REFER TO EXEMPTION # (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTILATOR FAILS INTERNAL LEAK TEST DURING PRE-USE CHECK. THERE WAS NO PATIENT INVOLVEMENT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    388825 SERVO-I CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1