BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPACELABS MEDICAL, INC.

    MDR report key: 352904 · Received September 24, 2001

    Report

    Report Number
    MW1022907
    Event Type
    Injury
    Date Received
    September 24, 2001
    Date of Event
    September 7, 2001
    Report Date
    September 14, 2001
    Manufacturer
    SPACELABS
    Product Code
    DXN
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    PORTABLE MONITOR WITH BP MODULE HAD BP CABLE ATTACHED TO PT'S ANTECUBITAL HEP LOCK. NO BP WAS CYCLED ON PT. PT WAS TRANSPORTED FROM ED TO CT WITH PORTABLE MONITOR. WHEN PT WAS BEING MOVED FROM THE ED BED TO CT TABLE, RN/TECH NOTED THAT BLOOD WAS COMING FROM MONITOR (BP MODULE). AT THAT POINT IT WAS NOTED BP CABLE WAS ATTACHED TO HEP LOCK. PT DISCONNECTED. VITAL SIGNS MONITORED. NO CHANGES NOTED IN PT CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    43259 SPACELABS MEDICAL, INC. BLOOD PRESSURE MODULE DXN SPACELABS 90351 *

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention 9/07/01.| 1) HEPARIN LOCK ALARIS MEDICAL, REF 2000E 108905