BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    Z VENT

    MDR report key: 24338224 · Received February 13, 2026

    Report

    Report Number
    1220908-2026-00468
    Event Type
    Malfunction
    Date Received
    February 13, 2026
    Report Date
    January 26, 2026
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    CBK
    UDI-DI
    00847946024185
    PMA / PMN Number
    K162832
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO ZOLL MEDICAL CORPORATION. DURING THE INVESTIGATION IT WAS NOTED THAT THE REPORTED PROBLEM RELATING TO THE CANT SWITCH MODES WAS VERIFIED. THE BUTTON BOARD WAS REPLACED TO REMEDY THE PROBLEM. THE DEVICE WAS RECERTIFIED AND RETURNED TO THE CUSTOMER. NO EMERGING TREND BASED ON SIMILAR REPORTS.

    Additional Manufacturer Narrative · 0

    ZOLL MEDICAL CORPORATION HAS NOT RECEIVED THE DEVICE FOR EVALUATION AND THIS COMPLAINT IS STILL UNDER INVESTIGATION.

    Description of Event or Problem · 0

    COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE WAS UNABLE TO SWITCH MODES. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    560511 Z VENT VENTILATOR CBK ZOLL MEDICAL CORPORATION 799-EMBP-05-01 NA 00847946024185

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown