BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNI-VENT MODEL 731

    MDR report key: 5402601 · Received February 1, 2016

    Report

    Report Number
    2242630-2016-00022
    Event Type
    Malfunction
    Date Received
    February 1, 2016
    Report Date
    January 19, 2016
    Manufacturer
    IMPACT PRODUCTS
    Product Code
    CBK
    PMA / PMN Number
    K111473
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE REPORTED COMPLAINT WAS DUPLICATED AND ATTRIBUTED TO AN "OLDER GENERATION" OXYGEN REGULATOR BEING USED WITH THIS DEVICE THAT DID NOT MONITOR THE EXCESSIVE HIGH LEVEL OF PRESSURE CAUSING THE 02 TUBE TO BECOME DISCONNECTED FROM THE SPM1 BOARD. THE REGULATOR IS NOT PART OF THE VENTILATOR OR DISTRIBUTED BY ZOLL. THE TUBES WERE RECONNECTED, THE DEVICE PASSED FINAL TESTING AND WAS RECERTIFIED FOR CLINICAL USE. IT IS IMPORTANT TO NOTE: NEW GENERATION OF REGULATORS WERE DISTRIBUTED TO THE CUSTOMER TO RESOLVE THIS PROBLEM CONDITION. THIS CLAIMS HAS BEEN CLOSED AS DEVICE MEETS SPECIFICATION. PLEASE REFERENCE SIMILAR CLAIMS UNDER MEDWATCH REPORTS; 2242630-2016-00018, 2242630-2016-00019 AND 2242630-2016-00020.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE AND GENDER UNKNOWN) THE DEVICE STOPPED WORKING DUE TO SUPPLY OF OXYGEN INTERRUPTED. 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
    61383 UNI-VENT MODEL 731 VENTILATOR CBK IMPACT PRODUCTS 800-EGL2-03 NA

    Patients

    Seq Age Sex Outcome Treatment
    1