BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNI-VENT MODEL 731

    MDR report key: 6170545 · Received December 13, 2016

    Report

    Report Number
    2242630-2016-00225
    Event Type
    Malfunction
    Date Received
    December 13, 2016
    Report Date
    November 23, 2016
    Manufacturer
    IMPACT PRODUCTS
    Product Code
    CBK
    PMA / PMN Number
    K111473
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE DEVICE DISPLAYED A "RUNTIME CALIBRATION FAILURE-1051" MESSAGE. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    820371 UNI-VENT MODEL 731 VENTILATOR CBK IMPACT PRODUCTS 799-EMVP-04 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1