BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHARIOT AMBULATOR

    MDR report key: 1383 · Received September 22, 1992

    Report

    Report Number
    1383
    Event Type
    Injury
    Date Received
    September 22, 1992
    Date of Event
    September 2, 1992
    Report Date
    September 10, 1992
    Manufacturer
    FIRST CHOICE INTERNATIONAL
    Product Code
    FKX
    Adverse Event
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    RESIDENT FOUND ON R. SIDE-CHARIOT AMBULATOR TIPPED OVER. RESIDENT TO EMERGENCY ROOM FOR SUTURES TO UPPER LIP, CHIN, FINGER. X-RAY OF R. SHOULDER NEGATIVE FOR FX. EXACT SEQUENCE OF EVENTS UNKNOWN AS OCCURRENCE NOT WITNESSED BUT IT IS FELT THAT LEG OF AMBULATOR GOT CAUGHT ON A TABLE LEG AND CAUSED AMBULATOR TO TIP OVERDEVICE 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. INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, OTHER, OTHER, INVALID DATA. RESULTS OF EVALUATION: TELEMETRY FAILURE, OTHER, ENVIRONMENTAL FACTORS, INVALID DATA. CONCLUSION: USER ERROR CAUSED EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: NO. CORRECTIVE ACTIONS: INSERVICED BY OTHER FACILITY STAFF. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CHARIOT AMBULATOR N/A FKX FIRST CHOICE INTERNATIONAL N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Required Intervention