BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-I

    MDR report key: 5454884 · Received February 23, 2016

    Report

    Report Number
    8010042-2016-00090
    Event Type
    Malfunction
    Date Received
    February 23, 2016
    Report Date
    March 11, 2015
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K123149
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FEB. 23, 2016 10:44 AM (GMT-5:00) ADDED BY (B)(6): THE REPORTED EDI CATHETER READING THE HIGH EDI PEAK PRESSURE WAS, ACCORDING TO THE RECEIVED INFORMATION, DUE TO A FAILURE IN THE EDI CATHETER, SINCE AFTER REPLACEMENT WITH A NEW ONE, THE VENT OPERATED FINE. THE REPLACED EDI CATHETER AS WELL AS THE DEVICE LOGS WERE NOT RECEIVED FOR THE INVESTIGATION, DESPITE SEVERAL REQUESTS HAVING BEEN MADE. A DEFECTIVE EDI CATHETER, WITH THE REPORTED SYMPTOMS, MAY LEAD TO A HIGHER VOLUMES BEING DELIVERED THAN WHAT WAS SET RESULTING IN HIGHER DELIVERED PRESSURES THAN INTENDED. THE ROOT CAUSE FOR THE EDI CATHETER FAILURE HAS NOT BEEN DETERMINED AS A RESULT OF THE LACK OF GOODS AND INFORMATION RECEIVED FOR THIS INVESTIGATION.

    Description of Event or Problem · 1

    FEB. 23, 2016 10:32 AM (GMT-5:00) ADDED BY (B)(6): THIS REPORT IS DUPLICATE OF ALREADY RECEIVE MDR WITH THE MANUFACTURER REPORT # : 8010042-2015-00128. THE RECORD IS BEING CREATED AS REQUESTED PER THE FDA CORRESPONDENCE THAT REQUIRES A SUPPLEMENTAL BE FILED ELECTRONICALLY. IT WAS REPORTED THAT WHILE THE VENTILATOR WAS CONNECTED TO A PATIENT, THE EDI CATHETER WAS READING A HIGH EDI PEAK PRESSURE AND WOULD NOT LOWER. THE EDI CATHETER WAS REPLACED WITH ANOTHER ONE WITH THE SAME LOT NUMBER. THE NEW CATHETER WORKED FINE AND NO PATIENT HARM WAS REPORTED. THE EDI CATHETER IS USED DURING NEURALLY ADJUSTED VENTILATORY ASSIST (NAVA) TO DETECT THE ELECTRICAL ACTIVITY IN THE DIAPHRAGM. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    112091 SERVO-I VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1