BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    E70 COUGH ASSIST

    MDR report key: 8692007 · Received June 12, 2019

    Report

    Report Number
    1040777-2019-00029
    Event Type
    Malfunction
    Date Received
    June 12, 2019
    Date of Event
    May 3, 2019
    Report Date
    May 21, 2019
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BYI
    PMA / PMN Number
    K122111
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN E70 COUGH ASSIST HAD PEAK PRESSURES HIGHER THAN EXPECTED WHEN TESTED. THE DEVICE WAS NOT IN PATIENT USE. THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. THE DEVICE FAILURE WAS FOUND DURING TEST AT THE REPORTING FACILITY. THE REPORTED INCIDENT OF THE IRREGULAR OSCILLATION PRESSURE WITH THE TRANSIENT PRESSURE OVERSHOOT WAS DUPLICATED DURING THE INVESTIGATION USING THE EXACT TEST SET-UP AND THE TEST SETTING DESCRIBED IN THE COMPLAINT RECORD. UNEVEN PRESSURE SETTINGS USED IN THE TESTING AT THE REPORTING FACILITY PUTS A GREATER BURDEN ON THE DYNAMIC PERFORMANCE OF THE OSCILLATION FEATURE. THE IMPACT OF THIS TRANSIENT OSCILLATION PRESSURE OVERSHOOT TO THE PATIENT IS ASSESSED LOCALLY BY THE MANUFACTURER WITH THE GOLD-STANDARD TEST SET-UP, INCLUDING THE STANDARD BACTERIA FILTER, THE TRACHEA MODELS, AND KEG TEST LUNG. THE TRANSIENT OSCILLATION PRESSURE OVERSHOOT DAMPENS TO AN ACCEPTABLE PRESSURE AMPLITUDE AT THE PATIENT LUNG, CONFIRMING THE SAFETY AND EFFICACY OF E70 OSCILLATION FEATURE.

    Description of Event or Problem · 1

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN E70 COUGH ASSIST HAD PEAK PRESSURES HIGHER THAN EXPECTED WHEN TESTED. THE DEVICE WAS NOT IN PATIENT USE. THE INVESTIGATION IS STILL ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER HAS COMPLETED THE INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    486580 E70 COUGH ASSIST PERCUSSOR, POWERED-ELECTRIC BYI RESPIRONICS, INC. 1098159

    Patients

    Seq Age Sex Outcome Treatment
    1