BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRESSSION

    MDR report key: 1280534 · Received January 2, 2009

    Report

    Report Number
    1022819-2008-00387
    Event Type
    Injury
    Date Received
    January 2, 2009
    Report Date
    October 12, 2007
    Manufacturer
    MJS HEALTHCARE BARTON INDUSTRIAL ESTATE
    Product Code
    JOW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE DISPLAY SHOWED TO BE DEFECTIVE WHEN EVALUATED BY CHATTANOOGA GROUP. THE LAB TEST UNIT AND THE NEW UNIT PULLED FROM STOCK BOTH WENT TO A MAXIMUM PRESSURE OF 2.0 PSI, BUT THE RETURNED COMPLAINANT UNIT WENT TO A MAXIMUM PRESSURE OF 2.5 PSI. THE RETURNED UNIT WAS RUN FOR ONE HOUR AND THE ON/OFF CYCLE ALWAYS WAS ABOUT 35 SECONDS ON AND 10 SECOND OFF. THE HIGHER PRESSURE OF 0.5 PSI CAN BE SENSED BY THE USER, BUT IT WAS NOT PAINFUL TO A NON-INJURED LEG. THE MANUAL STATED THAT THE MAXIMUM PRESSURE WOULD BE 100 +/- 5 MM HG, BUT SOME UNITS WILL NOT GO THAT HIGH. FOR SOME REASON, THE RA UNIT WENT TO ABOUT 25 % HIGHER PRESSURE THAN WHAT IS NORMAL. THE MANUFACTURER HAS BEEN CONTACTED ABOUT THIS, BUT NO RESPONSE HAS BEEN RECEIVED.

    Description of Event or Problem · 1

    DURING TREATMENT BY PNEUMATIC COMPRESSION TO LOWER LEFT EXTREMITY, PATIENT COMPLAINED OF PAIN. THE PATIENT RECEIVED MINOR BRUISING TO HER LOWER LEFT EXTREMITY. NO FURTHER PATIENT INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRESSSION COMPRESSION THERAPY DEVICE JOW MJS HEALTHCARE BARTON INDUSTRIAL ESTATE 4331

    Patients

    Seq Age Sex Outcome Treatment
    1 Other