BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SERVO-I

    MDR report key: 3952395 · Received June 25, 2014

    Report

    Report Number
    8010042-2014-00274
    Event Type
    Injury
    Date Received
    June 25, 2014
    Date of Event
    May 20, 2014
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K062793
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER INFORMATION SURROUNDING THE EVENT HAS BEEN SOUGHT. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED. (B)(4).

    Additional Manufacturer Narrative · 1

    THE VENTILATOR WAS INVESTIGATED BY THE HOSPITAL BIOMED. NO FAULT WAS FOUND AND NO PARTS WERE REPLACED. THE DEVICE LOGS WERE DOWNLOADED AND THE VENTILATOR WAS RETURNED TO SERVICE. ADDITIONAL INFORMATION STATED THAT THE PATIENT DESATURATED TO 80-85%, THE VENTILATOR WAS DISCONNECTED AND THE PATIENT WAS BAGGED WITH 100% O2. THE PATIENT STABILIZED AND WAS CONNECTED BACK TO THE VENTILATOR AND TRANSPORT WAS RESUMED. THE HOSPITAL FURTHER STATED THAT THE VENTILATOR DID NOT MALFUNCTION NOR HAD ANY TECHNICAL ISSUE. EVALUATION OF THE RECEIVED LOGS SHOWS THAT ONLY OXYGEN GAS SUPPLY WAS PRESENT DURING THE TRANSPORT. ALARMS FOR LOW GAS SUPPLY WERE GENERATED FREQUENTLY DURING 6 MINUTES INDICATING THAT THE VENTILATOR HAD NO SUPPLY PRESSURE (NO GAS). IN THE LAST MINUTE WERE ALSO ALARMS FOR APNEA, LOW MINUTE VOLUME, LOW RESPIRATORY RATE, LOW PEEP AND LOW OXYGEN CONCENTRATION INDICATION THAT THERE WAS NO VENTILATION. THE LOGS CONTAIN NO TECHNICAL ERROR ALARMS ON THE DAY OF EVENT AND THE LAST PRE-USE CHECK PRIOR TO VENTILATION PERIOD WAS SUCCESSFUL. THE CONCLUSION IN THE MATTER IS THAT THERE WAS NO VENTILATOR MALFUNCTION AT THE TIME. THE REPORTED EVENT WAS CAUSED BY LACK OF GAS TO THE VENTILATOR. ACCORDING TO THE RECEIVED LOGS, THE EVENT OCCURRED ON (B)(6) 2014 AND THE DATE OF EVENT HAS THEREFORE BEEN UPDATED. (B)(4).

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    369728 SERVO-I CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening