BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3100 HIGH FREQUENCY OSCILLATING VENTILATOR (HFOV)

    MDR report key: 5817646 · Received July 22, 2016

    Report

    Report Number
    2021710-2016-04104
    Event Type
    Malfunction
    Date Received
    July 22, 2016
    Date of Event
    June 10, 2016
    Report Date
    June 27, 2016
    Manufacturer
    CAREFUSION, INC
    Product Code
    LSZ
    PMA / PMN Number
    P890057
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ANY ADDITIONAL INFORMATION BE RECEIVED BY THE CUSTOMER THEN AN ADDITIONAL REPORT WILL BE SUBMITTED. (B)(4). DEVICE EVALUATION: THE CUSTOMER FIRST EVALUATED THE DEVICE AND DUPLICATED THE ISSUE WITH THE CIRCUIT BREAKER "SPARKING" INTERMITTENTLY. HE REPLACED THE CIRCUIT BREAKER BUT THIS DID NOT RESOLVE THE ISSUE. A CAREFUSION FIELD SERVICE REPRESENTATIVE (FSR) WENT ONSITE TO THE REPORTER'S FACILITY TO EVALUATE THE DEVICE. THE FSR DUPLICATED THE REPORTED ISSUE AND FOUND THAT WHEN THE CABLE FROM THE POWER SUPPLY TO THE PULSE WIDTH MODULE (PWM) AMPLIFIER WAS CONNECTED, IT CAUSED THE OVER-CURRENT CONDITION. THE FSR RECOMMENDED TO THE CUSTOMER TO REPLACE THE COMPONENT CONTAINING THE PWM AMPLIFIER, THE DRIVER CONTROLLER MODULE. THE FACTORY TRAINED CUSTOMER REPORTED THAT THEY WILL DO THE REPAIR.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A FEW WEEKS AGO HE REPLACED THE POWER CORD AND PERFORMED THE 12K PREVENTATIVE MAINTENANCE (PM) PROCEDURE ON THIS 3100A HIGH FREQUENCY OSCILLATING VENTILATOR, AND NOW THE END-USERS REPORTED THAT WHEN THEY DEPRESSED THE ON/OFF SWITCH, THE SWITCH "SPARKED" AND THE VENTILATOR POWERED DOWN. IT "SPARKED" OCCASIONALLY AND NOT EVERY TIME THE BUTTON WAS DEPRESSED. THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THIS REPORTED ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    469241 3100 HIGH FREQUENCY OSCILLATING VENTILATOR (HFOV) VENTILATOR, HIGH FREQUENCY LSZ CAREFUSION, INC 3100A

    Patients

    Seq Age Sex Outcome Treatment
    1