BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNI-VENT, MODEL 731

    MDR report key: 10883924 · Received November 23, 2020

    Report

    Report Number
    1220908-2020-03832
    Event Type
    Malfunction
    Date Received
    November 23, 2020
    Report Date
    November 6, 2020
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    CBK
    PMA / PMN Number
    K111473
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UZ
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER WAS CONTACTED FOR RETURN OF THE SUSPECT PRODUCT. THE PRODUCT HAS NOT BEEN RETURNED TO ZOLL FOR EVALUATION.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO ZOLL MEDICAL CORPORATION FOR EVALUATION. THE CUSTOMER'S REPORT WAS OBSERVED AND AN INTERNAL INSPECTION CONFIRMED DEBRIS INSIDE THE TRANSDUCER FLOW SCREENS. ALL TRANSDUCER SCREENS WERE REPLACED TO RESOLVE THE REPORT. THE DEVICE WAS RECERTIFIED AND RETURNED TO THE CUSTOMER. ANALYSIS OF REPORTS OF THIS TYPE HAS NOT IDENTIFIED AN INCREASE IN TREND.

    Additional Manufacturer Narrative · 1

    ZOLL MEDICAL CORPORATION HAS NOT RECEIVED THE DEVICE FOR EVALUATION AND THIS COMPLAINT IS STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE DISPLAYED "COMPRESSOR FAILURE -1001" AND "SELF CHECK FAILURE -1003" MESSAGES. COMPLAINANT INDICATED THAT THE CLINICIAN OBTAINED ANOTHER DEVICE TO CONTINUE TREATING THE PATIENT. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION. PLEASE REFERENCE MEDWATCH REPORT 1220908-2020-03830, 1220908-2020-03831, 1220908-2020-03792, 1220908-2020-03833, 1220908-2020-03834, 1220908-2020-03793, 1220908-2020-03835, 1220908-2020-03836, 1220908-2020-038320, 1220908-2020-03837, AND 1220908-2020-03838 FOR SIMILAR EVENTS REPORTED FROM THE SAME CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1351073 UNI-VENT, MODEL 731 VENTILATOR CBK ZOLL MEDICAL CORPORATION 799-EMVP-01-05 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown