BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MODEL EMV+ VENT, ARMY, COMMERCIAL

    MDR report key: 21066090 · Received January 3, 2025

    Report

    Report Number
    1220908-2024-04684
    Event Type
    Malfunction
    Date Received
    January 3, 2025
    Date of Event
    December 12, 2024
    Report Date
    December 13, 2024
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    CBK
    UDI-DI
    00847946023416
    PMA / PMN Number
    K162832
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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; THE CUSTOMER'S REPORT WAS OBSERVED DURING REVIEW OF THE DEVICE'S HISTORY LOG. THE DEVICE WAS PUT THROUGH EXTENSIVE TESTING WITH A KNOWN GOOD SET-UP WITHOUT DUPLICATING THE REPORT. THE O2 VALVE AND FLOW SCREENS WERE REPLACED AS A PRECAUTION. THE DEVICE PASSED THE FINAL TEST PROCEDURE, WAS RECERTIFIED, AND RETURNED TO THE CUSTOMER. ANALYSIS FOR REPORTS OF THIS TYPE HAS NOT IDENTIFIED AN INCREASE IN TREND.

    Description of Event or Problem · 0

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO VENTILATE A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE DISPLAYED "COMPRESSOR FAULT- 2001 ", "02 VALVE FAULT- 2011", AND "O2 VALVE FAULT- 3011" ERROR MESSAGES. 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
    457360 MODEL EMV+ VENT, ARMY, COMMERCIAL VENTILATOR CBK ZOLL MEDICAL CORPORATION 799-EMVP-01-01 NA 00847946023416

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown