BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IPV-1C

    MDR report key: 2950185 · Received January 16, 2013

    Report

    Report Number
    2950185
    Event Type
    Malfunction
    Date Received
    January 16, 2013
    Date of Event
    November 29, 2012
    Report Date
    January 16, 2013
    Manufacturer
    PERCUSSIONAIRE CORPORATION
    Product Code
    NHJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT, US

    Narratives

    Description of Event or Problem · 1

    RESPIRATORY TREATMENT WAS BRIEFLY STARTED (<10 SECONDS) WHEN HIGH PRESSURES OCCURRED USING THE INTRAPULMONARY PERCUSSIVE VENTILATOR (IPV) MACHINE. THE PATIENT'S HEART RATE DROPPED TO APPROXIMATELY 30 BEATS-PER-MINUTE AND IMMEDIATELY RETURNED TO NORMAL WITHIN 5 SECONDS. THE NURSE WITNESSED THE EVENT. STAFF FURTHER TESTED THE UNIT AND HIGH PRESSURES WERE NOTED AND THE MACHINE WAS NOT USED FURTHER. CALLED FOR OTHER RESPIRATORY THERAPISTS (RT'S) TO LOOK AT THE UNIT AND THEY ALSO FAILED TO SEE ANYTHING OBVIOUSLY WRONG WITH THE SETUP. THIS IPV MEDICAL TREATMENT WAS SKIPPED AS ANOTHER UNIT WAS NOT AVAILABLE.CLINICAL ENGINEERING STATES THAT THERE WAS A HARD FAILURE INSIDE THE MACHINE THAT CAUSED THE HIGH PRESSURE. MACHINE RETURNED TO MANUFACTURE.MANUFACTURE REPAIR NOTES INDICATE "REGULATOR CREEPS AND REGULATOR RING IS BROKEN, NEEDS REPLACED. METERING VALVE GOES UP TO FAST AND SLOW WHEN PUSHED ON THE STEM, NEEDS REPLACED. ADJUSTABLE BULK HEAD NEEDS REPLACED."======================MANUFACTURER RESPONSE FOR IPV MACHINE, IPV-1C (PER SITE REPORTER).======================SEE REPAIR NOTE IN EVENT SECTION.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?IPV RESPIRATORY TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25267 IPV-1C DEVICE, POSITIVE PRESSURE BREATHING NHJ PERCUSSIONAIRE CORPORATION IPV-1C *

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR