BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SSCOR, INC

    MDR report key: 23594851 · Received November 19, 2025

    Report

    Report Number
    2022724-2025-00002
    Event Type
    Malfunction
    Date Received
    November 19, 2025
    Report Date
    November 17, 2025
    Manufacturer
    SSCOR, INC
    Product Code
    BTA
    UDI-DI
    B2452310BV0
    PMA / PMN Number
    K945929
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    (B)(6) AMBULANCE SERVICES REPORTED THAT A VEHICLE FELL ON ADULT MALE IN A GARAGE, PATIENT HAD EMESIS IN AIRWAY, SUCTION UNIT BLINKED RED WHEN ATTEMPTING TO BE USED, BACK UP SUCTION UNIT WAS USED INSTEAD. ULTIMATELY THE SUCTION DEVICE DID NOT CONTRIBUTE TO THE PATIENT OUTCOME. WHEN ASKED IF THEY WOULD SEND THE DEVICE IN FOR EVAL, THEY REQUIRED A LOANER DEVICE. REPLACEMENT BATTERY WAS ISSUED AND THIS RESOLVED THEIR ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1520298 SSCOR, INC SSCOR VX-2 BTA SSCOR, INC 2310BV B2452310BV0

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male