BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIMS DELTEC, INC.

    MDR report key: 35318 · Received July 23, 1996

    Report

    Report Number
    35318
    Event Type
    Injury
    Date Received
    July 23, 1996
    Date of Event
    February 9, 1996
    Report Date
    February 27, 1996
    Manufacturer
    SIMS DELTEC, INC
    Product Code
    MEA
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    A PHYSICIAN FOUND A PT UNRESPONSIVE WITH OXYGEN SATURATION IN THE 40S. THE PT'S CONDITION RETURNED TO NORMAL AFTER RECEIVING OXYGEN. CLINICIANS SUSPECT AN ADVERSE REACTION TO PAIN MEDICATION OR OVER DELIVERY FROM A PCA PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIMS DELTEC, INC. PCA PUMP MEA SIMS DELTEC, INC 5800R NA

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Life Threatening