BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPACT

    MDR report key: 2622592 · Received June 14, 2012

    Report

    Report Number
    MW5025815
    Event Type
    Injury
    Date Received
    June 14, 2012
    Date of Event
    October 15, 2011
    Report Date
    June 14, 2012
    Manufacturer
    IMPACT INSTRUMENTATION INC.
    Product Code
    EOQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    MULTIPLE AND FREQUENT BATTERY FAILURES WITH IMPACT BRAND, PORTABLE EMS SUCTION UNITS. THIS PROBLEM IS AN EPIDEMIC IN EMS. THESE UNITS ARE BATTERY OPERATED WITH NO INDICATOR AS TO THE BATTERY¿S LIFE OR CAPACITY. OVER AND UNDERCHARGING END WITH THE SAME RESULTS; FAILURE. THE UNITS ARE NOT TO BE TESTED AS THIS WEARS DOWN THE BATTERY, SO THE WAY TO TEST THE BATTERIES IS TO USE THE UNIT ON A PT. IF THE BATTERY IS GOOD, THE UNIT WORKS, IF NOT THE UNIT IS EITHER DEAD OR WORKS FOR A MOMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMPACT IMPACT VAC-PAK II ULTRA-LITE EOQ IMPACT INSTRUMENTATION INC. 321

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization