BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARDIAC CHAIR

    MDR report key: 1130 · Received August 18, 1992

    Report

    Report Number
    1130
    Event Type
    Injury
    Date Received
    August 18, 1992
    Date of Event
    May 2, 1992
    Report Date
    July 28, 1992
    Manufacturer
    TEMPCO
    Product Code
    BYN
    Adverse Event
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    NURSING ASSISTANT WAS MOVING TABLE ATTACHED TO CARDIAC CHAIR. 5TH DIGIT, LEFT HAND ENTERED SMALL OPOENING BETWEEN TABLE AND CHAIR-RAIL, FINGER LACERATED REQUIRING (6) SIX SUTURESDEVICE 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 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: DESIGN - HUMAN FACTORS. CONCLUSION: USER ERROR CAUSED EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: UNKNOWN (CANNOT DETERMINE). CORRECTIVE ACTIONS: DEVICE PERMANENTLY REMOVED FROM SERVICE, OTHER. THE DEVICE WAS DESTROYED/DISPOSED OF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARDIAC CHAIR BYN TEMPCO

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention