BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-I

    MDR report key: 4838050 · Received June 9, 2015

    Report

    Report Number
    8010042-2015-00240
    Event Type
    Malfunction
    Date Received
    June 9, 2015
    Date of Event
    May 22, 2015
    Report Date
    May 23, 2015
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K123149
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE EDI-MODULE AND THE EDI-CATHETER CABLE WERE RETURNED FOR OUR INVESTIGATION. MICROSCOPIC INSPECTION OF THE EDI-MODULE SHOWED THAT THE PRINTED CIRCUIT BOARD HAS AN EXTENSIVE OXIDATION! CRYSTALLIZATION. OUR CONCLUSION IS THAT THE OXIDATION WAS CAUSED BY A LIQUID SPILL ON THE DEVICE, WITH A CONSEQUENCE OF A POTENTIAL SHORT CIRCUIT. THE DEVICE WAS MANUFACTURED IN 2011 AND HAS AN INGRESS PROTECTION DEGREE DUE TO APPLICABLE REQUIREMENTS AT THAT TIME. THE RECEIVED DEVICE LOGS EVALUATION ALSO CONFIRMED SEVERAL ALARMS, INDICATING A COMMUNICATION FAILURE TO THE EDI-MODULE. THE COMMUNICATION PROBLEM ALSO EFFECTED THE INTERNAL COMMUNICATION WITHIN THE VENTILATOR SUB-SYSTEMS. AS A RESULT OF THIS COMMUNICATION FAILURE THE PANEL UNIT DID NOT SHOW ANY CURVES AND MEASURES (I.E. THE PANEL WENT BLANK), THIS WAS MOST LIKELY INTERPRETED AS A STOPPAGE OF VENTILATION BY THE OPERATOR. THE DEVICE LOGS WERE NOT ABLE TO CONFIRM IF THE FAILURE MODE DID LEAD TO STOPPAGE OF VENTILATION SCENARIO OR NOT. VISUAL INSPECTION OF THE EDI-CABLE SHOWS NO DEVIATIONS. IT IS OUR CONCLUSION THAT THE EDI-CABLE IS FAULTLESS.

    Additional Manufacturer Narrative · 1

    FURTHER INFORMATION REGARDING THE EVENT HAS BEEN SOUGHT. A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTILATOR STOPPED DURING VENTILATION AND GENERATED AN ALARM SHORT AFTER THE EDI CABLE WAS RECONNECTED TO THE EDI MODULE. THE VENTILATOR WAS REPLACED WITH ANOTHER VENTILATOR. THERE WAS NO HARM TO THE PATIENT. THE EDI MODULE IS USED TOGETHER WITH THE EDI CATHETER DURING NAVA (NEURALLY ADJUSTED VENTILATORY ASSIST) TO DETECT THE ELECTRICAL ACTIVITY IN THE DIAPHRAGM. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370443 SERVO-I CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1