BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EMST150 EXPIRATORY MUSCLE STRENGTH TRAINER

    MDR report key: 20136093 · Received September 3, 2024

    Report

    Report Number
    MW5159203
    Event Type
    Injury
    Date Received
    September 3, 2024
    Date of Event
    August 23, 2024
    Report Date
    August 29, 2024
    Manufacturer
    ASPIRE PRODUCTS, LLC
    Product Code
    ION
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT WITH HISTORY OF COPD(CHRONIC OBSTRUCTIVE PULMONARY DISEASE) AND SUBPLEURAL BLEBS DEVELOPED L LUNG SPONTANEOUS PNEUMOTHORAX AFTER EMST (EXPIRATORY MUSCLE STRENGTH TRAINING) 150 BY ASPIRE. THIS OCCURS WITH INCREASING EXPIRATORY PRESSURE. IMPRESSION: SMALL TO MODERATE PNEUMOTHORAX AT THE LEFT LUNG BASE, AT THE LEFT COSTOPHRENIC ANGLE ANTERIORLY. NO DOCUMENTED PREVIOUS PNEUMOTHORAX COMPARED TO CT ON (B)(6) 2024. THE FINDING OF PNEUMOTHORAX WAS PREVIOUSLY CONVEYED ON CT ABDOMEN AND PELVIS REPORT. ADDITIONAL VERY THIN, TRACE, PNEUMOTHORAX AT THE LEFT LUNG APEX. NO EVIDENCE OF MEDIASTINAL SHIFT. EMPHYSEMA. THERE IS AN 8MM NODULE VERSUS FISSURAL LYMPH NODE IN THE ANTERIOR LEFT LOBE WHICH IS STABLE DATING BACK TO (B)(6) 2024, BUT NEWLY APPRECIATED FROM (B)(6) 2023. RECOMMEND CONTINUED IMAGING SURVEILLANCE IN 6-12 MONTHS. TREATMENT/THERAPY DATES: START (B)(6) 2024, STOP (B)(6) 2024. SKU: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    711541 EMST150 EXPIRATORY MUSCLE STRENGTH TRAINER EXERCISER, NON-MEASURING ION ASPIRE PRODUCTS, LLC 150

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male Hospitalization ELIQUIS .