BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IPV MACHINE

    MDR report key: 2809445 · Received October 24, 2012

    Report

    Report Number
    MW5027384
    Event Type
    Malfunction
    Date Received
    October 24, 2012
    Date of Event
    October 9, 2012
    Report Date
    October 15, 2012
    Manufacturer
    PERCUSSIONAIRE CORPORATION
    Product Code
    NHJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    CLIENT IS CARED FOR AT HOME AND HAS A TRACHEOSTOMY AND VENTILATOR. HIS CARE INCLUDES THE USE OF AN IPV (INTRAPULMONARY PERCUSSIVE VENTILATOR) EVERY 4 HRS ALONG WITH THE ADMINISTRATION OF VENTOLIN AND HYPERTONIC SALINE TO BE GIVEN WITH THE IPV. UPON ATTEMPT TO ADMINISTER TREATMENT, CLIENT WAS FOUND TO IMMEDIATELY DESATURATE PER HIS CONTINUOUS PULSE OXIMETER. THE MACHINE WAS IMMEDIATELY REMOVED AND THE DME COMPANY (PRO O2) THAT SUPPLIES THE MACHINE WAS CONTACTED TO FIX THE MACHINE. IT IS POSSIBLE THAT AN INCORRECT PART WAS PLACED ON THE MACHINE (ONE WAY VALVE INSTEAD OF A FLAPPER VALVE) WHICH CREATED THE INCREASING PRESSURE IN THE CLIENT¿S LUNGS. DATES OF USE: (B)(6) 2012 AND (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IPV MACHINE IPV MACHINE NHJ PERCUSSIONAIRE CORPORATION F00012

    Patients

    Seq Age Sex Outcome Treatment
    1 23 MO Other