BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPACT 73X PORTABLE VENTILATOR SYSTEM

    MDR report key: 4178512 · Received October 16, 2014

    Report

    Report Number
    2242630-2014-00007
    Event Type
    Malfunction
    Date Received
    October 16, 2014
    Date of Event
    August 22, 2013
    Report Date
    August 18, 2014
    Manufacturer
    IMPACT INSTRUMENTATION, INC.
    Product Code
    BTL
    PMA / PMN Number
    K051476
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    (B)(4). THIS SYSTEM WAS RETURNED FOR INTERNAL BATTERY PROBLEM. DURING THE INCOMING FUNCTIONAL TEST, THE ALARM FAILURE TRIGGER POINT WAS BELOW THE MINIMUM OF 10.6V. IT WAS DETERMINED THAT THE MAIN PCB WAS NOT FUNCTIONING CORRECTLY AND WAS REPLACED. THIS SYSTEM HAD PREVENTATIVE MAINTENANCE PERFORMED AND RETURNED TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    659187 IMPACT 73X PORTABLE VENTILATOR SYSTEM VENTILATOR BTL IMPACT INSTRUMENTATION, INC. 73X NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NONE REPORTED BY THE OPERATOR.