BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SERVO-I

    MDR report key: 852842 · Received May 11, 2007

    Report

    Report Number
    8010042-2007-00066
    Event Type
    Injury
    Date Received
    May 11, 2007
    Date of Event
    March 24, 2007
    Report Date
    April 16, 2007
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K063404
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    MAQUET INC. SUBMITS THIS REPORT ON BEHALF OF THE DEVICE MANUFACTURING FACILITY MAQUET CRITICAL CARE . MAQUET CRITICAL CARE PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE PT WAS DISCONNECTED FROM THE VENTILATOR AND TAKEN TO THE OPERATING THEATER. UPON RETURNING TO THE ROOM, THE PT WAS RECONNECTED TO THE VENTILATOR, WHICH HAD BEEN MAINTAINED IN STANDBY IN THE MEANTIME. AFTER A FEW MINUTES, THE MONITORING SHOWED A BLOOD PRESSURE DROP (46/35 MMHG) AND SEVERE BRADYCARDIA, WHILE AT THE SAME TIME VENTILATION CONTINUED WITHOUT ALARMS. THE MEDICAL STAFF NOTICED A GREAT THORACIC DISTENSION. THE PT WAS IMMEDIATELY DISCONNECTED FROM THE VENTILATOR AND A BIG QUANTITY OF AIR ESCAPED FROM THE PATIENT. THE BLOOD PRESSURE NORMALIZED AND THE PATIENT RECOVERED WITHOUT CLINICAL CONSEQUENCES. IT IS FURTHER REPORTED THAT AFTER DETAILED CHECKS, THE DOCTOR NOTICED THAT THE EXPIRATORY CASSETTE WAS NOT PROPERLY INSERTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention