BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OSCAR 2, 250D

    MDR report key: 9723832 · Received February 18, 2020

    Report

    Report Number
    1036863-2020-00002
    Event Type
    Malfunction
    Date Received
    February 18, 2020
    Date of Event
    November 27, 2019
    Report Date
    December 2, 2019
    Manufacturer
    SUNTECH MEDICAL, INC.
    Product Code
    DXN
    PMA / PMN Number
    K151500
    Removal / Correction Number
    84531
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SHORT CIRCUIT WAS CONFIRMED. IF THE BATTERIES ARE INSTALLED IN THE REVERSE POLARITY, WITHIN TWO TO THREE MINUTES, DEPENDING ON THE TYPE OF BATTERIES USED, THE TEMPERATURE OF THE BATTERY AND ASSOCIATED COMPONENTS SUCH AS THE BATTERY CONTACTS, CAN REACH TEMPERATURES IN EXCESS OF 140 DEGREES F. BURNS TO FINGERS AND HANDS ARE POSSIBLE FOR THE PATIENT AND/OR HEALTH CARE PROVIDER.

    Description of Event or Problem · 1

    CUSTOMER REPORTING THIS UNIT HAD AN OVERHEATING AT THE BATTERY SIGHT AND THAT IT MELTED WHEN THE BATTERIES WERE INSTALLED AND NO LONGER WORKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    186816 OSCAR 2, 250D SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE DXN SUNTECH MEDICAL, INC. 250D

    Patients

    Seq Age Sex Outcome Treatment
    1