BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    Z VENT

    MDR report key: 20409644 · Received October 9, 2024

    Report

    Report Number
    1220908-2024-03673
    Event Type
    Malfunction
    Date Received
    October 9, 2024
    Report Date
    September 18, 2024
    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 FOR EVALUATION. THE CUSTOMER REPORT OF THE DEVICE PROMPTING SELF-CHECK FAULTS/FAILURES, WAS OBSERVED UPON POWER UP AND IN THE DEVICE LOG. UPON POWER UP THE DEVICE ONLY PROMPTED A SELF-CHECK FAILURE 1001 ALARM. A REVIEW OF THE LOGS ALSO SHOWS A SELF-CHECK FAILURE 1172. THE EVENT DESCRIPTION INDICATES THE VENT WAS PLACED WITHIN INCHES OF THE MRI MACHINE BEFORE THE ALARMS WERE TRIGGERED. THE Z VENT OPERATOR'S GUIDE INDICATES THE VENTILATOR MUST BE PLACED BEHIND THE 130 GAUSS FIELD LINE (APPROXIMATELY 2 METERS TO THE BORE OPENING OF A 3T MRI MAGNET). ADDITIONAL PRECAUTIONS AND WARNINGS ARE INCLUDED IN THE OPERATOR'S GUIDE REGARDING USE IN AN MR ENVIRONMENT. THE DEVICE WAS USED AGAINST THE OPERATOR'S GUIDE'S "MRI CONDITIONAL EQUIPMENT" INSTRUCTIONS AND HAS SUBSEQUENTLY BEEN DETERMINED TO BE THE CAUSE OF REPORTED FAILURE CONDITION. THIS CUSTOMER WAS ON THE RECENT MRI VENT RECALL LIST AND WE HAVE CONFIRMATION THAT THIS CUSTOMER RECEIVED THE UPDATED LABELING. THIS EVENT OCCURRED POST RECALL WHICH IS WHY IT IS NOT REFERENCED IN H9. THE VENT MODULE ASSEMBLY, CPU BOARD, MINI USB CABLE, UIM BOARD, BUTTON BOARD, LCD DISPLAY, MASIMO ISOLATION ASSEMBLY AND MASIMO BOARD WILL BE REPLACED AS A PRECAUTION. THE DEVICE WILL BE RECERTIFIED AND RETURNED TO THE CUSTOMER. NO TREND IS ASSOCIATED WITH REPORTS OF THIS TYPE.

    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 "5V SELF CHECK FAILURE - 1172" AND "COMPRESSOR FAILURE -1001 " ERROR MESSAGES. 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
    1790322 Z VENT VENTILATOR CBK ZOLL MEDICAL CORPORATION 799-EMBP-05-01 NA 00847946024185

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown