BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNI-VENT MODEL 731

    MDR report key: 5936329 · Received September 8, 2016

    Report

    Report Number
    2242630-2016-00142
    Event Type
    Malfunction
    Date Received
    September 8, 2016
    Date of Event
    July 21, 2016
    Report Date
    August 19, 2016
    Manufacturer
    IMPACT PRODUCTS
    Product Code
    CBK
    PMA / PMN Number
    K111473
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED MALFUNCTION OF "DEVICE EMITTED A STRANGE SOUND" WAS NOT REPLICATED OR CONFIRMED. THE REPORTED MALFUNCTION OF "DEVICE'S DISPLAY WAS NOT READABLE" WAS ATTRIBUTED TO A FAULTY INTEGRATED CIRCUIT ON THE USER INTERFACE MODULE. ANALYSIS OF REPORTS OF THIS TYPE HAS NOT IDENTIFIED AN INCREASE IN TREND.

    Additional Manufacturer Narrative · 1

    ZOLL MEDICAL CORPORATION HAS RECEIVED THE PRODUCT AND WILL BE PROVIDING A FOLLOW-UP REPORT WHEN OUR INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A BABY (AGE & GENDER UNKNOWN), THE DEVICE EMITTED A STRANGE SOUND AND THE DISPLAY WAS NOT READABLE. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    589796 UNI-VENT MODEL 731 VENTILATOR CBK IMPACT PRODUCTS 799-EMVP-04 NA

    Patients

    Seq Age Sex Outcome Treatment
    1