BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-I

    MDR report key: 2870143 · Received December 6, 2012

    Report

    Report Number
    8010042-2012-00139
    Event Type
    Malfunction
    Date Received
    December 6, 2012
    Date of Event
    July 9, 2012
    Report Date
    November 9, 2012
    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
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    OUR FIELD SERVICE ENGINEER HAS BEEN ON SITE AND INVESTIGATED THE VENTILATOR. A PRINTED CIRCUIT BOARD WAS EXCHANGED. THE PC BOARD HAS BEEN REQUESTED BUT HAS NOT YET BEEN RETURNED. A SUPPLEMENTAL MEDWATCH WILL BE PROVIDED WHEN THE INVESTIGATION IS COMPLETED. REFERENCE EXEMPTION #: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTILATOR GENERATED A TECHNICAL ERROR INDICATING A FAILURE OF THE CONTROL PRINTED CIRCUIT BOARD DURING START-UP. THERE WAS NO PT INVOLVEMENT. (B)(4).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA