BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEIMLICH CHEST DRAIN VALVE

    MDR report key: 526 · Received April 30, 1992

    Report

    Report Number
    526
    Event Type
    Death
    Date Received
    April 30, 1992
    Date of Event
    February 15, 1992
    Report Date
    March 2, 1992
    Manufacturer
    BECTON DICKINSON AND COMPANY
    Adverse Event
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    THE PATIENT HAD CHEST TUBE IN PLACE ATTACHED TO A PLEUR EVAC AND EMEERSON PUMP. RN WENT IN TO REMOVE PLEUR EVAC AND PLACE THE HEIMLICH VALVE IN ORDER FOR THE PATIENT TO HAVE AN MRI SCAN OF THE HEAD COMPLETED. THE PATIENT WENT DOWN TO X-RAY. APPROX. ONE HOUR AND 15 MINUTES LATER, THE PATIENT WAS FOUND IN RESPIRATORY ARREST AND RESUSCITATION EFFORTS WERE UNSUCCESSFUL. IT WAS NOTED DURING THE CODE THAT THE VALVE HAD BEEN PLACED ON THE CHEST TUBE BACKWARDS. IT WAS TAKEN OFF AND PLACED CORRECTLY DURING THE CODEDEVICE 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 NOT USED AS LABELED/INDENDED.DEVICE WAS NOT EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: NO DATA. RESULTS OF EVALUATION: NO DATA. CONCLUSION: NO DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: DEVICE DISCARDED. THE DEVICE WAS DESTROYED/DISPOSED OF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEIMLICH CHEST DRAIN VALVE NI BECTON DICKINSON AND COMPANY NI UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Death