BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-S

    MDR report key: 4102496 · Received August 27, 2014

    Report

    Report Number
    8010042-2014-00345
    Event Type
    Malfunction
    Date Received
    August 27, 2014
    Date of Event
    August 5, 2014
    Report Date
    August 5, 2014
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K123149
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER HAS BEEN ON SITE AND HAS STARTED THE INVESTIGATION. A SUPPLEMENTAL MDR REPORT WILL BE SENT WHEN THE INVESTIGATION IS COMPLETED. (B)(4).

    Additional Manufacturer Narrative · 1

    THE RETURNED OXYGEN GAS MODULE WHICH REGULATES THE INSPIRATORY OXYGEN GAS FLOW TO THE PATIENT HAS BEEN INVESTIGATED. THE REPORTED PRE-USE CHECKS FAILURE WAS REPRODUCED DURING TESTING IN A REFERENCE VENTILATOR. INVESTIGATION SHOWED THAT THIS WAS CAUSED BY A DEFECTIVE PRINTED CIRCUIT BOARD (PCB) INSIDE THE OXYGEN GAS MODULE. THE PCB CONTAINS CIRCUITRY FOR FLOW MEASURING AND FLOW REGULATION. THE ROOT CAUSE FOR THE PCB'S FAILURE HAS NOT BEEN DETERMINED. DEVICE LOGS SHOWED THAT THE REPORTED FAILURE OCCURRED FOR THE FIRST TIME ON (B)(6) 2014 AND THEREFORE, THE DATE OF EVENT HAS BEEN UPDATED ACCORDINGLY.

    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).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    519085 SERVO-S CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1