BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    Z VENT

    MDR report key: 24233755 · Received February 2, 2026

    Report

    Report Number
    1220908-2026-00257
    Event Type
    Malfunction
    Date Received
    February 2, 2026
    Date of Event
    January 9, 2026
    Report Date
    January 12, 2026
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    CBK
    UDI-DI
    00847946024185
    PMA / PMN Number
    K162832
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO ZOLL MEDICAL CORPORATION, AND THE REPORTED ERROR CODE 1001 WAS CONFIRMED UPON POWER UP. IT WAS FURTHER CLARIFIED THAT THE ERROR CODE APPEARED AFTER THE DEVICE WAS INADVERTENTLY PULLED INTO AN MRI MACHINE. THE CUSTOMER WAS INCLUDED IN FSCA-Z-2130-2024 AND IT WAS CONFIRMED THAT THEY RESPONDED AND ACKNOWLEDGED RECEIPT. THE CUSTOMER REQUESTED THREE NEW QUICK REFERENCE GUIDES (QRG) WHICH WERE SHIPPED TO THEM ON 03JUN2024. THE UPDATED LABELING REQUIRES THAT THE DEVICE BE PROPERLY SECURED AND PLACED OUTSIDE OF THE 130 GAUSS LINE WHILE IN USE NEAR AN MRI MACHINE. THE CUSTOMER CONFIRMED THAT THEY DID NOT KNOW HOW CLOSE THE DEVICE WAS TO THE MRI WHEN IT WAS PULLED IN; THEREFORE, IT WAS LIKELY PLACED TOO CLOSE TO THE MACHINE. THE COMPRESSOR WAS LIKELY COMPROMISED AS A RESULT OF THE VENT BEING PULLED INTO THE MRI, CAUSING THE RELATED ERROR CODE 1001. THE COMPRESSOR WAS REPLACED AND THE DEVICE WAS RECERTIFIED AND RETURNED TO THE CUSTOMER. ANALYSIS OF REPORTS OF THIS TYPE HAS NOT IDENTIFIED AN INCREASE IN TREND.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE DISPLAYED A "COMPRESSOR FAILURE -1001 " ERROR MESSAGE. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299643 Z VENT VENTILATOR CBK ZOLL MEDICAL CORPORATION 799-EMBP-05-01 NA 00847946024185

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown