BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLEUR - EVAC A - 7000

    MDR report key: 6441 · Received August 31, 1993

    Report

    Report Number
    6441
    Event Type
    Injury
    Date Received
    August 31, 1993
    Date of Event
    July 30, 1993
    Report Date
    August 2, 1993
    Manufacturer
    DE KNATEL INC.
    Adverse Event
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    DIFFERENT DEGREES OF PNEUMOTHORAX, AS COMPARED TO ADMISSION DUE TO POSSIBLE PLEURO EVAC RED CHAMBER CRACKED ON 7/30/93. PLEURO - EVAC REPLACED AND ATTACHED TO LOW SUCTION. CHEST X-RAY ON 7/31/93 SHOWED FURTHER IMPROVEMENT COMPARED WITH CHEST X-RAY ON 7/30/93. NO EVIDENCE OF PNEUMOTHORAX REFLECTED ON CHEST X-RAY OF 8/1/93.DEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: FAIR 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, A DEVICE FROM SAME LOT WAS EVALUATED, PERFORMANCE TESTS PERFORMED, VISUAL EXAMINATION. RESULTS OF EVALUATION: TELEMETRY FAILURE, NONE OR UNKNOWN, NONE OR UNKNOWN, OTHER. CONCLUSION: OTHER. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: MAYBE. CORRECTIVE ACTIONS: OTHER. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLEUR - EVAC A - 7000 UNKNOWN DE KNATEL INC. UNKNOWN 6738 BW

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Other