BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNI-VENT, MODEL 731

    MDR report key: 14567095 · Received June 1, 2022

    Report

    Report Number
    1220908-2022-01953
    Event Type
    Malfunction
    Date Received
    June 1, 2022
    Report Date
    May 11, 2022
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    CBK
    PMA / PMN Number
    K111473
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO ZOLL MEDICAL CORPORATION; THE CUSTOMER'S REPORT WAS DUPLICATED AND ATTRIBUTED TO AN INTEGRATED CIRCUIT ON THE CENTRAL PROCESSING UNIT BOARD (CPU). THE CENTRAL PROCESSING UNIT BOARD WAS REPLACED TO RESOLVE THE CUSTOMER'S REPORT. THE DEVICE WAS RECERTIFIED AND RETURNED TO THE CUSTOMER. ANALYSIS FOR REPORTS OF THIS TYPE HAS NOT IDENTIFIED AN INCREASE IN TREND.

    Description of Event or Problem · 0

    COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE POWERED ON WITHOUT DISPLAY. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1426605 UNI-VENT, MODEL 731 VENTILATOR CBK ZOLL MEDICAL CORPORATION 799-EMVP-01-01 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown