BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-I

    MDR report key: 4092818 · Received August 20, 2014

    Report

    Report Number
    8010042-2014-00362
    Event Type
    Malfunction
    Date Received
    August 20, 2014
    Date of Event
    July 13, 2014
    Report Date
    July 24, 2014
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K123149
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER HAS BEEN ON SITE AND STARTED THE INVESTIGATION AND DOWNLOADED LOGS. INTERNAL LEAKAGE TEST FAILED DURING PRE-USE CHECK. THE AIR GAS MODULE WAS FOUND DEFECTIVE AND IT WAS REPLACED. THE DEFECTIVE PART HAS BEEN REQUESTED FOR INVESTIGATION, BUT NOT YET RECEIVED. RECEIVED DEVICE LOGS SHOW THAT THE FOLLOWING ALARMS WERE GENERATED ON THE REPORTED DATE OF EVENT: "PEEP HIGH" (POSITIVE END EXPIRATORY PRESSURE), "EXPIRATORY MINUTE VOLUME; LOW", O2 CONCENTRATION: HIGH" AND "RESPIRATORY RATE: HIGH". A SUPPLEMENTAL MDR REPORT WILL BE SENT WHEN THE INVESTIGATION IS COMPLETED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTILATOR MALFUNCTIONED WHILE CONNECTED TO A PATIENT. THERE WAS NO MORE INFO AVAILABLE ABOUT THE EVENT. THE VENTILATOR WAS TAKEN OFF PATIENT. THERE WAS NO HARM TO PATIENT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    500684 SERVO-I CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1