BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNI-VENT MODEL 731

    MDR report key: 4809207 · Received May 27, 2015

    Report

    Report Number
    2242630-2015-00006
    Event Type
    Malfunction
    Date Received
    May 27, 2015
    Report Date
    May 6, 2015
    Manufacturer
    IMPACT PRODUCTS
    Product Code
    CBK
    PMA / PMN Number
    K111473
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED MALFUNCTION WAS VERIFIED AND DETERMINED THAT THE DEVICE PERFORMED TO SPECIFICATION. THE REPORTED ALARMS WAS TO NOTIFY THE USE THAT OXYGEN WAS NOT BEING DELIVERED TO THE DEVICE. ONCE THE OXYGEN WAS TURNED ON, THE DEVICE WORKED AS EXPECTED. 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 · 1

    COMPLAINANT ALLEGED THAT WHILE TRANSPORTING A PATIENT, THE DEVICE GAVE RED CRITICAL ALARMS AND THE DEVICE DISPLAYED "CRITICAL ERROR" MESSAGE. COMPLAINANT INDICATED THEY SHUT THE DEVICE OFF AND TURNED IT BACK ON AND THE DEVICE WORKED OK. COMPLAINANT INDICATED THAT THERE WAS NO ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343199 UNI-VENT MODEL 731 IMPACT VENTILATOR CBK IMPACT PRODUCTS 800-EMVP-08 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK