BEUDAMED
    FDA Adverse Event Injury Summary report: N

    754 PORTABLE VENTILATOR

    MDR report key: 2809703 · Received October 22, 2012

    Report

    Report Number
    2242630-2012-00066
    Event Type
    Injury
    Date Received
    October 22, 2012
    Date of Event
    June 27, 2012
    Report Date
    October 19, 2012
    Manufacturer
    IMPACT INSTRUMENTATION, INC.
    Product Code
    CBK
    PMA / PMN Number
    K870861
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PROBLEM FOUND WITH DEVICE OUTPUT CABLE WHICH SHOWED INTERMITTENT CONNECTION AT THE TIP. THE CABLE APPEARED TO HAVE BEEN MODIFIED AND/OR A REPAIR WAS ATTEMPTED BY THE END USER. THE OUTPUT CABLE WAS REPLACED BY IMPACT'S SERVICE DEPARTMENT. THE DEVICE CPU AND ANALOG PC BOARDS AND THE PUMP HEAD WERE ALSO REPLACED. THE DEVICE SHOWED SIGNIFICANT EXTERNAL DAMAGE AND POSSIBLY RELATED FLUID INGRESS DUE TO ROUGH HANDLING.

    Description of Event or Problem · 1

    IMPACT 754 VENTILATOR WAS BEING USED ON A PATIENT WHEN THE TECHNICIAN REPORTED THAT THE DEVICE GAVE A "LOT BATTERY" ALARM. THE VENTILATOR WAS CONNECTED TO AC POWER HOWEVER, IT THEN BECAME OPERABLE AND APPEARED TO BE UNABLE TO CHARGE THE DEVICE BATTERY. THE END USER REPORTED THAT THERE WAS NO RESULTING SERIOUS INJURY TO THE PATIENT. THOUGH IT WAS REPORTED THAT SERIOUS INJURY TO THE PATIENT DID NOT OCCUR, WE HAVE SUBMITTED THIS AS A SERIOUS INJURY EVENT BECAUSE INTERVENTION USING BACK-UP VENTILATION EQUIPMENT MAY HAVE BECOME NECESSARY TO PRECLUDE PERMANENT IMPAIRMENT OR DAMAGE DUE TO THE DEVICE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 754 PORTABLE VENTILATOR VENTILATOR CBK IMPACT INSTRUMENTATION, INC. 754 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R NONE REPORTED BY THE OPERATOR