BEUDAMED
    FDA Adverse Event Death Summary report: N

    S-SCORT...JR QUICKDRAW

    MDR report key: 1712843 · Received June 2, 2010

    Report

    Report Number
    2022724-2010-00001
    Event Type
    Death
    Date Received
    June 2, 2010
    Date of Event
    May 4, 2010
    Report Date
    May 28, 2010
    Manufacturer
    SSCOR INC.
    Product Code
    BTA
    PMA / PMN Number
    K041154
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    WE HAVE NOT RECEIVED THE DEVICE INVOLVED IN THIS INCIDENT FOR EVAL AND INVESTIGATION. IN ADDITION, WE WERE UNABLE TO REVIEW THE DEVICE HISTORY RECORD SINCE THE DEVICE SERIAL NUMBER WAS NOT PROVIDED. AS THE INITIAL REPORTER STATED, THE DEVICE INVOLVED IN THIS INCIDENT HAD NOT BEEN KEPT AT CHARGE ALL THE TIMES; THE INITIAL REPORTER BELIEVES, THE PATIENT'S DEATH WAS NOT RELATED TO USE OF THE SSCOR SUCTION DEVICE INVOLVED IN THIS INCIDENT. FOR THIS REASON, HE DID NOT WANT TO SEND THE DEVICE FOR EVAL. THE DEVICE INVOLVED IN THIS INCIDENT IS A BATTERY OPERATED PORTABLE SUCTION DEVICE AND NEEDS TO BE KEPT ON CONTINUOUS CHARGE AS STATED IN THE PRODUCT MANUAL. BASED ON THE INFO RECEIVED FROM THE INITIAL REPORTER, WE BELIEVE THAT THE SUCTION DEVICE (QUICKDRAW, MODEL #2400) INVOLVED IN THIS INCIDENT DID NOT CAUSE OR CONTRIBUTE TO THE PATIENT'S OUTCOME.

    Description of Event or Problem · 1

    ON (B) (6) 2010, THE HEALTH CARE PROFESSIONAL REPORTED TO SSCOR, INC. THAT THE SUCTION DEVICE (QUICKDRAW, MODEL #2400) DID NOT FUNCTION PROPERLY ON A CALL DEALING WITH A PATIENT. THE HEALTH CARE PROVIDER ALSO REPORTED THAT THE PATIENT HAD BLOOD IN THEIR AIRWAY AND THE BLOOD WAS "TRICKLING" UP THE TUBE. THE HEALTH CARE PROFESSIONAL REPEATEDLY TOOK THE CANISTER ON AND OFF, BUT NOTICED NO DIFFERENCE. AFTER ATTEMPTING MANY TIMES TO GET MORE DETAILED INFO FROM THE INITIAL REPORTER, ON (B) (6) 2010, WE DISCOVERED THAT THE PATIENT INVOLVED IN THIS INCIDENT ACTUALLY PASSED AWAY. THE INITIAL REPORTER STATED THAT THE PT'S DEATH WAS NOT RELATED TO USE OF THE SSCOR DEVICE. THE DEVICE WAS NOT KEPT AT CHARGE ALL THE TIMES. HE BELIEVES, THIS CAUSED THE DEVICE FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 S-SCORT...JR QUICKDRAW 2400 QUICKDRAW BTA SSCOR INC. 2400 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death