BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNI-VENT, MODEL 731

    MDR report key: 9993029 · Received April 23, 2020

    Report

    Report Number
    1220908-2020-01117
    Event Type
    Death
    Date Received
    April 23, 2020
    Date of Event
    April 1, 2020
    Report Date
    April 2, 2020
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    CBK
    UDI-DI
    00847946020620
    PMA / PMN Number
    K111473
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: THE DEVICE WAS RETURNED TO ZOLL MEDICAL CORPORATION; THE CUSTOMERS REPORT WAS DUPLICATED AND ATTRIBUTED TO A FAULTY AUTOCAL VALVE ON THE SMART PNEUMATIC MODULE BOARD. THE DEVICE 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 MONITOR A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE DISPLAYED A "RUNTIME CALIBRATION FAILURE - 1051" MESSAGE. COMPLAINANT INDICATED THAT THE CLINICIAN OBTAINED ANOTHER DEVICE TO CONTINUE TREATING THE PATIENT. COMPLAINANT INDICATED THAT THE PATIENT SUBSEQUENTLY EXPIRED, HOWEVER IT WAS NOT A RESULT OF THE REPORTED MALFUNCTION. PLEASE REFERENCE MEDWATCH REPORT 1220908-2020-01233 FOR A SIMILAR EVENT REPORTED FROM THE SAME CUSTOMER.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO MONITOR A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE DISPLAYED A "CRITICAL ALARM WARNING" MESSAGE. COMPLAINANT INDICATED THAT THE CLINICIAN OBTAINED ANOTHER DEVICE TO CONTINUE TREATING THE PATIENT. COMPLAINANT INDICATED THAT THE PATIENT SUBSEQUENTLY EXPIRED, HOWEVER IT WAS NOT A RESULT OF THE REPORTED MALFUNCTION. PLEASE REFERENCE MEDWATCH REPORT 1220908-2020-01233 FOR A SIMILAR EVENT REPORTED FROM THE SAME CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    455854 UNI-VENT, MODEL 731 VENTILATOR CBK ZOLL MEDICAL CORPORATION 799-EMVP-04 NA 00847946020620

    Patients

    Seq Age Sex Outcome Treatment
    1 Death