BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-I

    MDR report key: 3915170 · Received May 13, 2014

    Report

    Report Number
    8010042-2014-00213
    Event Type
    Malfunction
    Date Received
    May 13, 2014
    Date of Event
    April 5, 2014
    Report Date
    April 15, 2014
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K062793
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) REPLACED THE EXPIRATORY CASSETTE AND DOWNLOADED THE VENTILATOR LOG FILES. AFTER REPLACEMENT OF EXPIRATORY CASSETTE THE PRE-USE CHECKS PASSED SUCCESSFULLY AND THE VENTILATOR WAS THEREFORE RETURNED BACK TO SERVICE. THE DEVICE LOTS EVALUATION CONFIRMED THAT THE PRE-USE CHECKS FAILURE SEVERAL TIMES ON (B)(6) AND ALSO ON (B)(6). THEREFORE, THE DATE OF EVENT IS REVISED TO BE THE (B)(6). THE DEVICE LOGS SHOWED THAT IT WAS THE SUB-TEST INTERNAL LEAKAGE TEST THAT WAS FAILING IN THE PRE-USE CHECKS. THERE ARE NO OTHER ENTRIES IN THE TECHNICAL LOG FILES INDICATING A PERMANENT DEVICE MALFUNCTION. THE FAULTY EXPIRATORY CASSETTE WAS NOT RECEIVED BACK FOR OUR ANALYSIS AND THE CUSTOMER COULD NOT PROVIDE ANY ADDITIONAL INFORMATION AS TO HOW THE VENTILATOR GOT ACCIDENTALLY WET. IT IS OUR CONCLUSIONS THAT THE EXPIRATORY CASSETTE WAS THE CAUSE OF THE UNSUCCESSFUL PRE-USE CHECKS AND THAT IT MOST LIKELY WAS AFFECTED NEGATIVELY BY THIS WET INCIDENT. THE TRUE CAUSE OF THE FAILING EXPIRATORY CASSETTE CANNOT BE ESTABLISHED, AS IT WAS NOT RECEIVED AND FURTHER INVESTIGATED DURING OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. A SUPPLEMENTAL REPORT WILL BE PROVIDED WHEN INVESTIGATION IS COMPLETED. REFERENCE EXEMPTION #: (B)(4).

    Description of Event or Problem · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER CALLED FOR SERVICE BECAUSE THE VENTILATOR BECAME WET. AS A CONSEQUENCE, THE VENTILATOR DID NOT PASS THE PRE-USE CHECK. THERE WAS NO PATIENT INVOLVEMENT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    285566 SERVO-I CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1