BEUDAMED
    FDA Adverse Event Death Summary report: N

    SSCOR/BOARD

    MDR report key: 346336 · Received August 7, 2001

    Report

    Report Number
    2022724-2001-00001
    Event Type
    Death
    Date Received
    August 7, 2001
    Date of Event
    June 27, 2001
    Report Date
    August 7, 2001
    Manufacturer
    SSCOR, INC.
    Product Code
    BTA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON 7/2001, SSCOR, INC. RECEIVED A TELEPHONE CALL FROM FACILITY. FACILITY IS AN AMBULANCE MFR THAT PURCHASES CO'S SSCOR/BOARD SUCTION UNITS AND INSTALLS THEM IN ITS AMBULANCES. FACIITY INFORMED SSCOR THAT THEY HAD RECEIVED A REPORT FROM ANOTHER FACILITY TO THE EFFECT THAT A PT HAD DIED WHILE BEING TRANSPORTED WITH THE OTHER FACILITY AMBULANCE AND THAT THE DR ON BOARD THE AMBULANCE MAY HAVE INDICATED THAT THE SSCOR SUCTION UNIT WAS NOT WORKING PROPERLY AND COULD HAVE CONTRIBUTED TO THE PT'S DEATH. AS OF THIS DATE, THE REPORTED INCIDENT REMAINS UNCONFIRMED DESPITE SSCOR'S REPEATED ATTEMPTS TO ACQUIRE ADDITIONAL INFO, SPECIFICALLY TELEPHONE REQUESTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35778 SSCOR/BOARD SUCTION SYSTEM FOR PERMANENT INSTALLATION IN PT TRANS. VEHIC BTA SSCOR, INC. 22000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death