BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNI-VENT MODEL 731

    MDR report key: 5463733 · Received February 26, 2016

    Report

    Report Number
    2242630-2016-00029
    Event Type
    Malfunction
    Date Received
    February 26, 2016
    Report Date
    February 10, 2016
    Manufacturer
    IMPACT PRODUCTS
    Product Code
    CBK
    PMA / PMN Number
    K111473
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ZOLL MEDICAL CORPORATION EVALUATED THE DEVICE AND THE REPORTED MALFUNCTION WAS NOT REPLICATED OR CONFIRMED. THE DEVICE WAS PUT THROUGH EXTENSIVE TESTING WHICH INCLUDED ENVIRONMENTAL AND FUNCTIONAL TESTING WITHOUT DUPLICATING THE MALFUNCTION. THE DEVICE'S WYE CIRCUIT WAS NOT AVAILABLE FOR EVALUATION AS PART OF THIS INVESTIGATION. THE DEVICE'S AUTOCALIBRATION VALVE WAS REPLACED AS A PRECAUTION. THE DEVICE WAS RECERTIFIED AND RETURNED TO THE CUSTOMER. NO TREND IS ASSOCIATED WITH REPORTS OF THIS TYPE.

    Additional Manufacturer Narrative · 1

    ZOLL MEDICAL CORPORATION HAS RECEIVED THE PRODUCT AND WILL BE PROVIDING A FOLLOW-UP 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 A "RUN TIME CALIBRATION ERROR - 1051" MESSAGE. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION. PLEASE REFERENCE MEDWATCH REPORT NUMBER 2242630-2016-00030 FOR A SIMILAR REPORT FROM THE SAME CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    119620 UNI-VENT MODEL 731 VENTILATOR CBK IMPACT PRODUCTS 799-AEV1-01 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1