BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-I

    MDR report key: 3971157 · Received April 29, 2014

    Report

    Report Number
    8010042-2014-00199
    Event Type
    Malfunction
    Date Received
    April 29, 2014
    Report Date
    April 3, 2014
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K062793
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HOSPITAL WILL DO ITS REPAIR BUT FURTHER INFORMATION SURROUNDING THE EVENT HAS BEEN SOUGHT AND REQUEST OF PARTS HAS BEEN DONE. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED. (B)(4).

    Additional Manufacturer Narrative · 1

    OUR INVESTIGATION OF THIS COMPLAINT HAS BEEN COMPLETED. IT IS BASED ON THE RECEIVED DEVICE LOG FILES THAT WERE PROVIDED. NO GOODS OR PICTURES WERE RETURNED, IN ORDER TO DEMONSTRATE THE DESCRIBED CONTAMINATION OF "DRIED MATTER." THE DEVICE LOG EVALUATION CONFIRMED SEVERAL SOFTWARE WARNINGS (BETWEEN DATES 03/27/2014 TO 04/03/2014) REGARDING THE PANEL SUB-SYSTEM. THIS MIGHT BE RELATED TO THE PROBLEM DESCRIPTION WHERE THE WORDING OF "DISPLAY LOCKED UP" WAS USED, MEANING THAT THE USER INTERFACE INTERMITTENTLY FREEZES OR BECAME DISTURBED. A SOFTWARE WARNING REGARDING THE PANEL SUB-SYSTEM WILL NOT AFFECT ON-GOING VENTILATION. EXCEPT FOR THE SOFTWARE WARNINGS THERE ARE NO RECORDINGS IN THE TECHNICAL LOG FILES TO INDICATE A VENTILATOR MALFUNCTION.

    Description of Event or Problem · 1

    THE HOSPITAL BIOMED REPORTED THAT THE SCREEN OF THE VENTILATOR GOT LOCKED UP AND WHEN THE VENTILATOR WAS BROUGHT TO THE SHOP IT WAS OBSERVED THAT THERE WAS DRIED MATTER ON SEVERAL PRINTED CIRCUIT BOARDS. THE DATE OF THE EVENT AND PATIENT INFORMATION ARE UNKNOWN. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256201 SERVO-I CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1