BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOLL Z-VENT

    MDR report key: 19089537 · Received April 10, 2024

    Report

    Report Number
    MW5153741
    Event Type
    Malfunction
    Date Received
    April 10, 2024
    Date of Event
    April 4, 2024
    Report Date
    April 9, 2024
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    REPORTED THAT WHILE TRANSPORTING A PATIENT EXPERIENCING SHORTNESS OF BREATH, THEY EXPERIENCED EQUIPMENT FAILURE WHILE UTILIZING THE ZOLL VENT. THE ZOLL VENT PASSED THE INSPECTION THIS MORNING, HOWEVER ON THIS PATIENT IT READ ON THE SCREEN SYSTEM FAILURE, AND INDICATED NO OXYGEN WAS REACHING THE UNIT. THE UNIT WAS PLUGGED IN WITH THE HARD O2 LINE ATTACHED. TROUBLE SHOOTING WAS UNSUCCESSFUL. M29 RENDEZVOUSED WITH M9 AND UTILIZED THEIR VENT FOR THE DURATION OF TRANSPORT. PATIENT STABLE ON ARRIVAL TO HOSPITAL. WITH VENT WAS TAKEN AND IS BEING SENT TO LOGISTICS FOR MAINTENANCE AND DIAGNOSTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    808673 ZOLL Z-VENT VENTILATOR, CONTINUOUS, FACILITY USE CBK ZOLL MEDICAL CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male