BEUDAMED
    FDA Adverse Event Injury Summary report: N

    Z VENT

    MDR report key: 23586776 · Received November 18, 2025

    Report

    Report Number
    1220908-2025-04342
    Event Type
    Injury
    Date Received
    November 18, 2025
    Date of Event
    August 30, 2025
    Report Date
    October 28, 2025
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    CBK
    PMA / PMN Number
    K162832
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THROUGH ADDITIONAL FOLLOW UPS WITH THE END USER, IT WAS IDENTIFIED THAT THIS IS A DUPLICATE COMPLAINT WHICH WAS ALREADY REPORTED UNDER MANUFACTURER REPORT NUMBER: 1220908-2025-03518. THE INITIAL REPORT WAS SUBMITTED TO THE FDA ON 24SEP2025. THE SUPPLEMENTAL REPORT WAS SUBMITTED TO THE FDA ON 16DEC2025. PLEASE REFER TO THE SUPPLEMENTAL MDR #1220908-2025-03518-01 FOR RESULTS OF THE INVESTIGATION FINDINGS PREVIOUSLY SUBMITTED ON 16DEC2025.

    Additional Manufacturer Narrative · 0

    JUSTIFICATION FOR NO UDI: THIS DEVICE HAS A UDI; SOME INFORMATION WAS NOT PROVIDED AND IS UNKNOWN; THEREFORE, A COMPLETE UDI CANNOT BE PROVIDED. ZOLL MEDICAL CORPORATION HAS NOT RECEIVED THE DEVICE FOR EVALUATION AND THIS COMPLAINT IS STILL UNDER INVESTIGATION.

    Description of Event or Problem · 0

    THROUGH ADDITIONAL FOLLOW UPS WITH THE END USER, IT WAS IDENTIFIED THAT THIS IS A DUPLICATE COMPLAINT WHICH WAS ALREADY REPORTED UNDER MANUFACTURER REPORT NUMBER: 1220908-2025-03518. THE INITIAL REPORT WAS SUBMITTED TO THE FDA ON 24SEP2025. THE SUPPLEMENTAL REPORT WAS SUBMITTED TO THE FDA ON 16DEC2025.

    Description of Event or Problem · 0

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A 68-YEAR-OLD MALE PATIENT, THE DEVICE INAPPROPRIATELY SHUT DOWN. COMPLAINANT INDICATED THAT THE PATIENT SUBSEQUENTLY SUSTAINED A SERIOUS INJURY. THE CUSTOMER WAS UNABLE TO PROVIDE INFORMATION ON THE PATIENT'S INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2326346 Z VENT VENTILATOR CBK ZOLL MEDICAL CORPORATION 799-EMBP-05-01 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Other