BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXIOL FERNO ILLE

    MDR report key: 3792 · Received July 8, 1992

    Report

    Report Number
    3792
    Event Type
    Malfunction
    Date Received
    July 8, 1992
    Date of Event
    June 26, 1992
    Report Date
    June 30, 1992
    Manufacturer
    FOLLO INDUSTRIES A/S
    Product Code
    FQO
    Product Problem
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS CHANGING POSITION ON TABLE WHEN IT SUDDENLY HINGED UPWARD AT THE CENTER CAUSING "JARRING" OF PATIENT.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.DEVICE SERVICED IN ACCORDANCE WITH SERVICE SCHEDULE. DATE LAST SERVICED: 01-SEP-91. SERVICE PROVIDED BY: USER FACILITY BIOMEDICAL/BIOENGINEERING DEPARTMENT. INVALID DATA - SERVICE RECORDS AVAILABILITY. NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, PERFORMANCE TESTS PERFORMED. RESULTS OF EVALUATION: NONE OR UNKNOWN. CONCLUSION: THERE WAS NO DEVICE FAILURE, USER ERROR CAUSED EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: NO. CORRECTIVE ACTIONS: DEVICE REPAIRED AND PUT BACK IN SERVICE, DEVICE TEMPORARILY REMOVED FROM SERVICE, USER EDUCATION PROVIDED. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXIOL FERNO ILLE ELECTRIC MOBILIZATION TABLE FQO FOLLO INDUSTRIES A/S 4000

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Other