BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNI-VENT, MODEL 731

    MDR report key: 12692737 · Received October 25, 2021

    Report

    Report Number
    1220908-2021-03587
    Event Type
    Malfunction
    Date Received
    October 25, 2021
    Date of Event
    October 2, 2021
    Report Date
    October 4, 2021
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    CBK
    UDI-DI
    00847946023416
    PMA / PMN Number
    K111473
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL MEDWATCH REPORT IS REPORTING THE EVALUATION OF THE DEVICE AND CORRECTING INFORMATION SUBMITTED ON THE INITIAL MEDWATCH REPORT. DEVICE EVALUATION: THE DEVICE WAS RETURNED TO ZOLL MEDICAL CORPORATION AND THE CUSTOMER'S REPORT WAS OBSERVED DURING REVIEW OF THE DEVICE ACTIVITY LOGS. HOWEVER, THE DEVICE WAS PUT THROUGH EXTENSIVE TESTING WITHOUT DUPLICATING THE REPORT. SPO2 SHUTDOWN COMMUNICATION BETWEEN THE PULSE OXIMETER MODULE AND THE UNIT FAILS AND THE OPERATOR HAS TURNED OFF PULSE OXIMETER MONITORING ACKNOWLEDGING THE CONDITION. WHEN THIS IS DONE, STBY APPEARS IN THE DATA WINDOWS FOR SPO2 AND HR AS THOSE PARAMETERS ARE NO LONGER AVAILABLE. THE VENTILATOR WILL CONTINUE TO OPERATE JUST WITHOUT THESE PARAMETERS. THE MASIMO MODULE WAS REPLACED AS A PRECAUTION. THE DEVICE WAS RECERTIFIED AND RETURNED TO THE CUSTOMER. ANALYSIS FOR REPORTS OF THIS TYPE HAS NOT IDENTIFIED AN INCREASE IN TREND. REPORTS OF THIS NATURE ARE NOT CONSIDERED TO MEET OUR REQUIREMENTS FOR SUBMISSION OF A MEDWATCH REPORT DUE TO NO POTENTIAL FOR CLINICAL IMPACT.

    Description of Event or Problem · 0

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE DISPLAYED AN "INTERNAL COMM FAILED - 3301" ERROR MESSAGE. COMPLAINANT INDICATED THAT THERE WAS NO ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.

    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 TREAT A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE DISPLAYED AN UNKNOWN "SELF TEST FAULT" ERROR MESSAGE. 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
    1587800 UNI-VENT, MODEL 731 VENTILATOR CBK ZOLL MEDICAL CORPORATION 799-EMVP-01-01 NA 00847946023416

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown