BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-I

    MDR report key: 1912507 · Received November 19, 2010

    Report

    Report Number
    8010042-2010-00260
    Event Type
    Malfunction
    Date Received
    November 19, 2010
    Date of Event
    June 30, 2010
    Report Date
    November 1, 2010
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K062793
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED PRINTED CIRCUIT CONTROL BOARD HAS BEEN INVESTIGATED. THE REPORTED GAS SUPPLY TEST FAILURE DURING PRE-USE CHECK WAS REPRODUCED. THE PRINTED CIRCUIT BOARD WAS FOUND WITH A FAULTY CAPACITOR. THE COMPONENT FAULT AFFECTS THE OXYGEN INLET PRESSURE-SIGNAL TO THE PRINTED CIRCUIT CONTROL BOARD. THIS ERRONEOUS SIGNAL IS INTERPRETED AS IF THE INLET OXYGEN GAS SUPPLY PRESSURE IS LOW AND THEREBY CAUSING THE OXYGEN GAS MODULE TO STOP DELIVERING OXYGEN. THIS FAILURE WILL BE NOTICED DURING THE PRE-USE CHECK. SHOULD THIS FAILURE OCCUR DURING PT TREATMENT THE VENTILATOR WILL CONTINUE TO VENTILATE WITH AIR ONLY. ALARM FOR LOW OXYGEN CONCENTRATION WILL BE GENERATED IF THE CONCENTRATION GETS BELOW THE SET VALUE BY MORE THAN 6 VOL. %. THE REASON WHY THE CAPACITOR FAILED WAS INSUFFICIENT INSULATION IN THE CAPACITOR. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTILATOR FAILED THE GAS SUPPLY TEST DURING PRE-USE CHECK. (B)(4).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1