BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O2 TANK E CYLINDER

    MDR report key: 4286062 · Received November 19, 2014

    Report

    Report Number
    4286062
    Event Type
    Malfunction
    Date Received
    November 19, 2014
    Date of Event
    November 12, 2014
    Report Date
    November 19, 2014
    Manufacturer
    LINDE GAS NORTH AMERICA
    Product Code
    ECX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    A NEW AND FULL O2 TANK WAS PUT ONTO THE TRANSPORT CART AND TURNED ON AFTER REMOVING THE RED TAB. IN APPROXIMATELY 5 MINUTES, THE TANK WAS EMPTY. A NEW TANK WAS OBTAINED AND USED WITHOUT ILL EFFECTS TO THE PATIENT. THE PATIENT'S OXYGEN WAS SET AT 12 LITER PER NC AND THAT SHOULD HAVE LASTED 56 MINUTES ON THE NEW TANK.======================MANUFACTURER RESPONSE FOR O2 TANK E CYLINDER, (BRAND NOT PROVIDED) (PER SITE REPORTER).======================I HAVE TALKED TO CUSTOMER SERVICE AT LINDE. I ASKED HIM THESE QUESTIONS: 1. HOW DO YOU THINK SOMETHING LIKE THIS COULD HAPPEN?2. HAS THIS BEEN HAPPENING AT OTHER ORGANIZATIONS?3. DO YOU KNOW HOW THIS COULD BE PREVENTED FROM HAPPENING AGAIN?HE COULD NOT ANSWER THEM. HE SAID HE WOULD LET THE PLANT MANAGER KNOW AND THAT HE WOULD BE CONTACTING ME. APPROXIMATELY ONE WEEK LATER, I SENT THE SAME QUESTIONS TO THE PLANT MANAGER ALONG WITH A REQUEST TELLING HIM TO PICK UP THE O2 TANK AND THAT I NEEDED A FOLLOW UP INVESTIGATION LETTER SENT TO ME ONCE THE TANK WAS CHECKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    750398 O2 TANK E CYLINDER CYLINDER, COMPRESSED GAS, AND VALVE ECX LINDE GAS NORTH AMERICA * 287E401

    Patients

    Seq Age Sex Outcome Treatment
    1 * NO OTHER THERAPIES