BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRESS ECHOBED

    MDR report key: 2554820 · Received April 26, 2012

    Report

    Report Number
    1932056-2012-00003
    Event Type
    Injury
    Date Received
    April 26, 2012
    Date of Event
    April 23, 2012
    Report Date
    April 26, 2012
    Manufacturer
    MEDICAL POSITIONING, INC.
    Product Code
    DPS
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON INVESTIGATION IT WAS FOUND THAT THE TECH WAS NOT USING THE PRODUCT ACCORDING TO USER INSTRUCTIONS. THE SUPERVISOR OF THE DEPT WHO MADE THE REPORT TO MEDICAL POSITIONING INC STATED THAT THE TECHS HAD BEEN TRAINED TO NOT FORCE THE ERGOMETER. IT IS APPARENT THAT MISUSE RATHER THAN DEVICE DEFECT CAUSED THE EVENT.

    Description of Event or Problem · 1

    TWO ECHO TECHS WERE ATTEMPTING TO REMOVE THE ERGOMETER (EXERCISE BIKE) FROM THEIR STRESS ECHOBED. THE ERGOMETER BECAME STUCK IN THE TRACK AND WOULD NOT MOVE AT WHICH POINT THE TECHS BEGAN USING MORE PUSHING/PULLING FORCE TO REMOVE THE ERGOMETER. AT SOME POINT THE FORCE PLACED ON THE ERGOMETER ALLOWED THE ERGOMETER TO RELEASE, HOWEVER IT CAUSED ENOUGH MOMENTUM TO PROPEL THE ERGOMETER OFF THE END OF THE STRESS ECHOBED. THE ERGOMETER FELL TO THE GROUND LANDING ON THE FOOT OF ONE OF THE TECHS AND BROKE THE FOOT. NO PT WAS INVOLVED IN THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRESS ECHOBED STRESS ECHOBED OR SEB DPS MEDICAL POSITIONING, INC. 1724

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention