BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    Z VENT

    MDR report key: 20106680 · Received August 30, 2024

    Report

    Report Number
    1220908-2024-03127
    Event Type
    Malfunction
    Date Received
    August 30, 2024
    Date of Event
    August 11, 2024
    Report Date
    August 12, 2024
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    CBK
    UDI-DI
    00847946024185
    PMA / PMN Number
    K162832
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO ZOLL MEDICAL CORPORATION FOR EVALUATION. THE CUSTOMER'S REPORT WAS OBSERVED AND ATTRIBUTED TO DIRECT CONTACT WITH MRI MAGNET. THE DEVICE WAS PUT THROUGH EXTENSIVE TESTING WITHOUT DUPLICATING THE REPORT. THE VENT MODULE ASSEMBLY, CPU BOARD, MASIMO BOARD, MINI USB CONNECTOR, BUTTON BOARD, UIM BOARD, LCD DISPLAY, BUZZER, MASIMO ISOLATION ASSEMBLY AND MAIN BATTERY WERE REPLACED DUE TO DEVICE COMING IN DIRECT CONTACT WITH MRI MAGNET. THE DEVICE WAS RECERTIFIED AND RETURNED TO THE CUSTOMER. ZOLL VENTILATOR OPERATOR'S GUIDE STATES THE FOLLOWING: YOU MUST SECURE THE DEVICE TO A SUITABLE MRI-COMPATIBLE CART. YOU MUST PLACE THE VENTILATOR BEHIND THE 130 GAUSS FIELD LINE (APPROXIMATELY 2 METERS TO THE BORE OPENING OF A 3T MRI MAGNET). THE VENTILATOR MUST BE ATTENDED BY A PERSON WITH NO OTHER RESPONSIBILITY THAN MONITORING THE DEVICE AND PATIENT WHILE IN THE MRI ENVIRONMENT. TWELVE-FOOT PATIENT CIRCUITS ARE AVAILABLE FOR USE WITH THE VENTILATOR, THE ADDITIONAL LENGTH ENABLES A SUITABLE SEPARATION BETWEEN THE VENTILATOR AND THE MRI BORE OPENING. NO TREND IS ASSOCIATED WITH REPORTS OF THIS TYPE.

    Description of Event or Problem · 0

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO VENTILATE A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE DISPLAYED A "COMPRESSOR FAILURE - 1001" ERROR MESSAGE AND THE DEVICE WOULD NOT RESPOND TO INPUT SELECTIONS VIA THE FRONT PANEL. COMPLAINANT INDICATED THAT THE CLINICIAN OBTAINED ANOTHER DEVICE TO CONTINUE TREATING THE PATIENT. 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
    1356433 Z VENT VENTILATOR CBK ZOLL MEDICAL CORPORATION 799-EMBP-05-01 NA 00847946024185

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown