BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SSCOR INC

    MDR report key: 17321817 · Received July 13, 2023

    Report

    Report Number
    2022724-2023-00002
    Event Type
    Malfunction
    Date Received
    July 13, 2023
    Date of Event
    June 15, 2023
    Report Date
    July 13, 2023
    Manufacturer
    SSCOR INC
    Product Code
    BTA
    UDI-DI
    B2452310BV0
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SSCOR REACHED OUT TO INITIAL REPORTER TO OBTAIN ADDITIONAL INFORMATION. INITIAL REPORTER STATED THAT THEY RECEIVED A CALL FOR A 68 YEAR OLD MALE IN CARDIAC ARREST AND DEVICE DID NOT HAVE ENOUGH SUCTION. WHEN DEVICE WAS TAKEN OFF THE BRACKET IT HAD A FULL GREEN LED, BUT THEN THE ORANGE AND RED LED LIGHT STARTED BLINKING. BACK UP DEVICE (SSCORT III) WAS USED TO SUCTION . REPORTER ALSO STATED THAT BATTERY HAS NOT BEEN REPLACED SINCE DEVICE WAS PURCHASED ON 02/22/2019. PER INITIAL REPORTER BATTERY MALFUNCTION DID NOT CAUSE OR CONTRIBUTE TO OUTCOME OF PATIENT. DEVICE WAS NOT RETURNED FOR EVALUATION. BATTERY MALFUNCTION IS TYPICALLY DUE TO POOR BATTERY MAINTENANCE. SSCOR HAS ADVISED REPORTER TO REPLACE BATTERY EVERY 3 YEARS AND PERFORM BATTERY TESTS AS STATED IN PRODUCT MANUAL. SSCOR HAS ISSUED A REPLACEMENT BATTERY.

    Description of Event or Problem · 0

    BATTERY FAILED DURING A CARDIAC ARREST CALL. UNIT WILL TURN ON BUT THERE WAS NOT ENOUGH SUCTION. SSCORT III WAS USED AS BACK UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    766451 SSCOR INC SSCOR VX-2 BTA SSCOR INC 2310BV N/A B2452310BV0

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male