BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-S

    MDR report key: 3963682 · Received May 8, 2014

    Report

    Report Number
    8010042-2014-00204
    Event Type
    Malfunction
    Date Received
    May 8, 2014
    Date of Event
    May 2, 2014
    Report Date
    May 2, 2014
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K041223
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279575 SERVO-S CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1