BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-I

    MDR report key: 3960824 · Received June 27, 2014

    Report

    Report Number
    8010042-2014-00279
    Event Type
    Malfunction
    Date Received
    June 27, 2014
    Date of Event
    May 2, 2014
    Report Date
    June 2, 2014
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K123149
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEFECTIVE PARTS HAVE BEEN REQUESTED BACK FOR INVESTIGATION. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED. (B)(4).

    Additional Manufacturer Narrative · 1

    THE ON-SITE INVESTIGATION BY OUR FIELD SERVICE ENGINEER SHOWED THAT THE OXYGEN GAS MODULE WAS CAUSING THE REPORTED FLOW TRANSDUCER SUB-TEST FAILURE DURING THE PRE-USE CHECKS. THE GAS MODULE WAS REPLACED BY THE HOSPITAL'S BIOMEDICAL ENGINEER AND THE DEFECTIVE PART WAS KEPT BY THE CUSTOMER. THE REPORTED PROBLEM WAS CONFIRMED IN THE RECEIVED VENTILATOR'S LOGS SHOWING THAT THE FLOW TRANSDUCER SUB-TEST FAILED DUE TO A LOWER FLOW DELIVERY FROM THE OXYGEN GAS MODULE. THE OXYGEN GAS MODULE REGULATES THE OXYGEN GAS FLOW TO THE PATIENT. A FAILURE OF THIS COMPONENT MIGHT LEAD TO LOWER OXYGEN CONCENTRATION THAN SET. THE TRUE CAUSE FOR THE OXYGEN GAS MODULE'S FAILURE HAS NOT BEEN DETERMINED SINCE IT WASN'T RETURNED FOR FURTHER INVESTIGATION AND ANALYSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTILATOR FAILED THE FLOW TRANSDUCER TEST DURING PRE-USE CHECK. THERE WAS NO PT INVOLVEMENT. (B)(4).

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    375984 SERVO-I CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1