BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S-SCORT II

    MDR report key: 8903900 · Received August 16, 2019

    Report

    Report Number
    2022724-2019-00005
    Event Type
    Malfunction
    Date Received
    August 16, 2019
    Date of Event
    July 11, 2019
    Report Date
    August 16, 2019
    Manufacturer
    SSCOR INC.
    Product Code
    JCX
    PMA / PMN Number
    K791210
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS RECEIVED JULY 23, 2019 FOR EVALUATION. SSCOR WAS UNABLE TO DUPLICATE THE ISSUE REPORTED. WHEN TESTED THE DEVICE MET SSCOR SPECIFICATIONS ALTHOUGH THE DEVICE IS 15 YEARS OLD AND HAS REACHED ITS LIFE. OUTCOME OF THE PATIENT IN UNKNOWN. INITIAL REPORTER WAS UNABLE TO INDICATE HOW LONG THE DEVICE WAS RUNNING/SUCTIONING PROPERLY BEFORE THEY TURNED IT OFF. WHEN THEY GOT BACK TO THE STATION, THEY TRIED TO DUPLICATE THE ISSUE AND THEY COULDN'T, THEY STATED THE DEVICE POWERED ON. THE DEVICE WAS RETURNED TO THE STATION ON 08/13/2019.

    Description of Event or Problem · 1

    "HAD A CALL ABOUT A POOL SIDE DROWNING PATIENT. THEY GOT THE PATIENT OUT AND WERE IN THE PROCESS OF INTUBATING THE PATIENT. THEY HAD THE S-SCORT II RUNNING AND SUCTIONING, THEY THEN TURNED THE DEVICE OFF BECAUSE THEY NO LONGER NEEDED IT AND WHEN THEY TRIED TO TURN IT BACK ON IT WOULD NOT TURN ON. THEY IMMEDIATELY MOVED THE PATIENT TO THE AMBULANCE AND CONTINUED SUCTIONING WITH A SEPARATE DEVICE. I DO NOT BELIEVE THERE WAS ANY SIGNIFICANCE TO THE OUTCOME, BECAUSE THE DELAY WAS NOT LONG. THEY JUST HAD TO CHANGE THE COURSE OF ACTION. I AM NOT SURE HOW LONG THE DEVICE WAS RUNNING BEFORE THEY TURNED IT OFF. WE TRIED TO DUPLICATE THE ISSUE AT THE STATION AND COULDN'T."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    694858 S-SCORT II S-SCORT II JCX SSCOR INC. 15006 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR