BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINDE OXYGEN TANKS (PORTABLE)

    MDR report key: 5196918 · Received October 30, 2015

    Report

    Report Number
    MW5057598
    Event Type
    Injury
    Date Received
    October 30, 2015
    Date of Event
    October 10, 2015
    Report Date
    October 30, 2015
    Manufacturer
    LINDE GAS NORTH AMERICA
    Product Code
    BYJ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    CALLER REPORTS HIS WIFE RECEIVED PORTABLE OXYGEN TANKS FROM (B)(6) ON (B)(6) 2015. AFTER USING THE PUMP FOR A DAY HIS WIFE COMPLAINED THE DEVICE EMITS AN ODOR. SHE FELL ILL AND WAS SENT TO THE E. R. WHERE SHE WS DIAGNOSED WITH INFLAMED LUNGS. HER BLOOD PRESSURE DROPPED AND SO DID HER OXYGEN SATURATION. SHE RECEIVED ANTIBIOTICS AND HAD A CT SCAN WHICH SHOWED NO SIGN OF PNEUMONIA. SHE WAS DISCHARGED TO A REHAB FACILITY AFTER 5 DAYS IN THE HOSPITAL. THE PHYSICAL CONDITION OF THE TANK IS VERY WORN; THE LABEL HAS PEELED OFF WITH GLUE RESIDUE ON THE TANK. THE LOT NUMBER IS UNREADABLE AND THE PUMP "LOOKS LIKE IT HAS GONE THROUGH WORLD WAR III. CALLER WANTS THIS TANK INVESTIGATED AS HE BELIEVES MADE HIS WIFE SICK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722548 LINDE OXYGEN TANKS (PORTABLE) LINDE OXYGEN TANKS (PORTABLE) BYJ LINDE GAS NORTH AMERICA UN1072

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other