BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SSCOR INC

    MDR report key: 19281296 · Received May 9, 2024

    Report

    Report Number
    2022724-2024-00002
    Event Type
    Malfunction
    Date Received
    May 9, 2024
    Date of Event
    April 4, 2024
    Report Date
    May 9, 2024
    Manufacturer
    SSCOR INC.
    Product Code
    BTA
    UDI-DI
    B24523140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SSCOR REACHED OUT TO REPORTER TO OBTAIN ADDITIONAL INFORMATION, REPORTER STATED THAT ON 4/4 GENERAL HOSPITAL IN GRAND JUNCTION COLORADO HAD A CALL FOR A PATIENT THAT WAS ON ONCOLOGY THERAPY THAT WENT INTO CARDIAC ARREST. REPORTER STATED THAT THE DEVICE WAS ON THE CRASH CART, BUT ONCE DISCONNECTED FROM THE WALL IT WILL NO POWER ON. AN ALTERNATE DEVICE WAS USED. CUSTOMER WAS ADVISED THAT DEVICES ARE TO BE MAINTAINED ON CHARGE WHEN NOT IN USE PER PRODUCT MANUAL. REPORTER STATED THAT DEVICE WAS NOT PLACED ON CHARGE FOR THE LAST 4 OR 5 MONTHS AND IT WAS JUST PLACE INTO SERVICE (B)(6) 2024. A REPLACEMENT BATTERY WAS SENT TO CUSTOMER, BUT CUSTOMER ISSUE WAS NOT RESOLVED. AFTER TROUBLE SHOOTING DEVICE WITH TECH SUPPORT IT WAS DETERMINED THAT THE FAILURE WAS DUE TO A NON CONFORMING PC BOARD. CUSTOMER WAS SENT A REPLACEMENT PC BOARD. THE CUSTOMER CONFIRMED THAT REPLACING THEIR 80540 BOARD SOLVED THE ISSUE WITH THE DEVICE FAILING TO POWER ON.

    Description of Event or Problem · 0

    2314 FAILED TO OPERATE ON BATTERY POWER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    489535 SSCOR INC SSCOR DUET BTA SSCOR INC. 2314 B24523140

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose