BEUDAMED
    FDA Adverse Event Other Summary report: N

    CYBEX NORM ISOKINETIC UNIT

    MDR report key: 112938 · Received July 25, 1997

    Report

    Report Number
    112938
    Event Type
    Other
    Date Received
    July 25, 1997
    Date of Event
    March 7, 1997
    Report Date
    March 10, 1997
    Manufacturer
    CYBEX
    Product Code
    IKK
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT WAS STRAPPED ON THE CYBEX MACHINE IN THE PASSIVE RANGE OF MOTION MODE FOR LEFT KNEE FLEXION AND EXTENSION. WHEN THE MACHINE WAS STARTED IT BEAT THE PT'S LEFT KNEE BACK INTO FLEXION FURTHER THAN THE ANTICIPATED RANGE OF MOTION BEFORE THE EMERGENCY STOP CONTROL COULD BE ACTIVATED. THE MECHANICAL STOPS WERE NOT SET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYBEX NORM ISOKINETIC UNIT TESTING AND REHABILITATION SYSTEM IKK CYBEX NORM *

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other