BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNI-VENT, MODEL 731

    MDR report key: 10868233 · Received November 19, 2020

    Report

    Report Number
    1220908-2020-03682
    Event Type
    Malfunction
    Date Received
    November 19, 2020
    Report Date
    October 30, 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

    THIS SUPPLEMENTAL MEDWATCH REPORT IS REPORTING THE EVALUATION OF THE DEVICE. THIS SUPPLEMENTAL MEDWATCH REPORT IS ALSO CORRECTING INFORMATION SUBMITTED ON THE INITIAL MEDWATCH REPORT. EVALUATION RESULTS: THE CUSTOMER'S REPORT WAS OBSERVED DURING THE POWER UP EVALUATION. INTERNAL INSPECTION CONFIRMED DEBRIS INSIDE THE TRANSUCER FLOW SCREENS. ALL OF THE TRANSDUCER FLOW 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.

    Description of Event or Problem · 0

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE DISPLAYED A"SELF CHECK FAILURE -1003" MESSAGE. COMPLAINANT INDICATED THAT THE CLINICIAN MANUALLY VENTILATED THE PATIENT TO CONTINUE TREATMENT. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION. PLEASE REFERENCE MEDWATCH REPORTS 1220908-2020-03676, 1220908-2020-03677, 1220908-2020-03678, 1220908-2020-03679, 1220908-2020-03680 AND 1220908-2020-03681 FOR SIMILAR EVENTS REPORTED FROM THE SAME CUSTOMER.

    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 A"SELF CHECK FAILURE -1003" MESSAGE AND STOPPED VENTILATING. COMPLAINANT INDICATED THAT THE CLINICIAN MANUALLY VENTILATED THE PATIENT TO CONTINUE TREATMENT. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION. PLEASE REFERENCE MEDWATCH REPORTS 1220908-2020-03676, 1220908-2020-03677, 1220908-2020-03678, 1220908-2020-03679, 1220908-2020-03680 AND 1220908-2020-03681 FOR SIMILAR EVENTS REPORTED FROM THE SAME CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1335011 UNI-VENT, MODEL 731 VENTILATOR CBK ZOLL MEDICAL CORPORATION 799-EMVP-01-05 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown