BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-I

    MDR report key: 3894165 · Received February 6, 2014

    Report

    Report Number
    8010042-2014-00017
    Event Type
    Malfunction
    Date Received
    February 6, 2014
    Date of Event
    January 16, 2014
    Report Date
    January 16, 2014
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K062793
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    A SERVICE TECHNICIAN HAS BEEN ON SIGHT. FURTHER INFORMATION HAS BEEN SOUGHT AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED AFTER THE INVESTIGATION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTILATOR GENERATED A TECHNICAL ERROR CODE INDICATING AN INTERNAL MEMORY ERROR AND A DISABLED VALVE. THERE WAS NO HARM TO THE PATIENT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78810 SERVO-I CBK MAQUET CRITICAL CARE AB NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA