BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNI-VENT MODEL 731

    MDR report key: 5795797 · Received July 14, 2016

    Report

    Report Number
    2242630-2016-00104
    Event Type
    Malfunction
    Date Received
    July 14, 2016
    Report Date
    June 24, 2016
    Manufacturer
    IMPACT PRODUCTS
    Product Code
    CBK
    PMA / PMN Number
    K111473
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THIS MEDWATCH REPORT WAS SUBMITTED IN ERROR. PLEASE REFERENCE MEDWATCH REPORT 2242630-2016-00118 FOR THIS REPORTED MALFUNCTION.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN) THE DEVICE DISPLAYED AN "INTERNAL COMM ERROR 1471" MESSAGE. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    449842 UNI-VENT MODEL 731 VENTILATOR CBK IMPACT PRODUCTS 799-EMVP-04 NA

    Patients

    Seq Age Sex Outcome Treatment
    1