BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EQUALIZER 6.0S

    MDR report key: 1118 · Received August 18, 1992

    Report

    Report Number
    1118
    Event Type
    Malfunction
    Date Received
    August 18, 1992
    Date of Event
    June 25, 1992
    Report Date
    July 28, 1992
    Manufacturer
    PRO-FORM FITNESS PRODUCTS, INC.
    Product Code
    IOL
    Product Problem
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    WHILE RESIDENT WAS EXERCISING, MACHINE ABRUPTLY, DUE TO A MALFUNCTION, WENT FROM APPROXIMATELY 15 MPH TO 4.5 + MPH. MACHINE WAS STOPPED. RESIDENT LOST BALANCE BUT WAS CAUGHT BY THERAPIST AND HAD NO INJURY. MACHINE TAKEN OUT OF SERVICE AND STORE WHERE PURCHASED CALLED UNDER WARRANTYDEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY. NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE NOT USED AS LABELED/INDENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, OTHER, OTHER, INVALID DATA. RESULTS OF EVALUATION: ELECTRICAL PROBLEM. CONCLUSION: INTERMITTENT FAILURE DIRECTLY CAUSED EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: DEVICE TEMPORARILY REMOVED FROM SERVICE, OTHER, OTHER. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EQUALIZER 6.0S TREADMILL IOL PRO-FORM FITNESS PRODUCTS, INC. 086146-0 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other