BEUDAMED
    FDA Adverse Event Summary report: N

    SEQUENTIAL COMPRESSION DEVICE (SCD)

    MDR report key: 832040 · Received March 15, 2007

    Report

    Report Number
    1219977-2007-00001
    Date Received
    March 15, 2007
    Date of Event
    February 1, 2007
    Report Date
    February 12, 2007
    Manufacturer
    *
    Product Code
    DSQ
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    SUSPECT MEDICAL DEVICE LISTED IS NOT MANUFACTURED BY ATRIUM MEDICAL CORP. HOWEVER, IT IS POSSIBLE THAT AN ATRIUM CHEST DRAIN MAY HAVE BEEN CONNECTED TO THE SUSPECT MEDICAL DEVICE DESCRIBED AS A SEQUENTIAL COMPRESSION DEVICE ON THE MEDWATCH FORM SUBMITTED. ATRIUM CHEST DRAINS ARE NOT TO BE USED BY LAY PEOPLE, ONLY BY TRAINED MEDICAL PERSONNEL.

    Description of Event or Problem · 1

    PATIENT DISCONNECTED SEQUENTIAL COMPRESSION DEVICE (SCD'S) AS WELL AS THE SUCTION TO HIS CHEST TUBE WATER SEAL DRAINAGE TO GO TO THE BATHROOM. UPON RETURN TO THE BEDSIDE, THE PATIENT CONNECTED THE SCD DEVICE IN ERROR TO THE CHEST TUBE WATER SEAL DRAINAGE DEVICE. THE SCD ALARM IMMEDIATELY ALERTED THE NURSE TO THE MISCONNECTION. THE M.D. WAS NOTIFIED AND A CHEST X-RAY (CXR) WAS DONE WITH NO APPARENT HARM TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEQUENTIAL COMPRESSION DEVICE (SCD) PNEUMATIC COMPRESSION DEVICE (SCD) DSQ * 2600 *

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR