BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-I

    MDR report key: 3823852 · Received February 21, 2014

    Report

    Report Number
    8010042-2014-00050
    Event Type
    Malfunction
    Date Received
    February 21, 2014
    Date of Event
    January 27, 2014
    Report Date
    January 30, 2014
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K062793
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    OUR FIELD SERVICE ENGINEER WAS ON-SITE AND DOWNLOADED THE DEVICE LOGS. NO INVESTIGATION WAS PERFORMED AT THAT TIME. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE CUSTOMER AS TO HOW THE PROBLEM WAS RESOLVED, BUT NO INFORMATION HAS BEEN RECEIVED. EVALUATION OF THE RECEIVED DEVICE TEST LOGS SHOWED THAT THE INTERNAL LEAKAGE, THE PRESSURE TRANSDUCER, AND THE SAFETY VALVE SUB-TESTS OF THE PRE-USE CHECKS FAILED BECAUSE NO PRESSURE COULD BE BUILT UP IN THE VENTILATOR. THESE FAILURES IN THE PRE-USE CHECKS INDICATE A LEAKAGE. THE LOGS DO NOT CONTAIN ANY TECHNICAL ALARMS THAT INDICATE THERE WAS A TECHNICAL VENTILATOR FAILURE AT THE TIME. THE REPORTED FAILURE CAN BE CONFIRMED IN THE RECEIVED DEVICE LOGS BUT, WE HAVE BEEN UNABLE TO DETERMINE THE ROOT CAUSE IS BASED ON THE LIMITED INFORMATION THAT WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTILATOR WAS FAILING THE INTERNAL LEAKAGE TESTS DURING PRE-USE CHECKS DISPLAYING THE EXCESSIVE LEAKAGE ERROR MESSAGE. IT WAS FURTHER STATED THAT THE VENTILATOR HAS AN INTERNAL BUILDUP OF CORROSION. THERE WAS NO PATIENT INVOLVEMENT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    109689 SERVO-I CBK MAQUET CRITICAL CARE AB NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA