BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAMSUNG

    MDR report key: 9617491 · Received January 22, 2020

    Report

    Report Number
    1125873-2020-00001
    Event Type
    Malfunction
    Date Received
    January 22, 2020
    Report Date
    January 2, 2020
    Manufacturer
    VISICU, INC - DUP
    Product Code
    MSX
    UDI-DI
    00884838084452
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION AND OBJECTIVE EVIDENCE REVEALED NO BURNING, MELTING OR CHARRING OF THE ADAPTOR OR CORD. THE ADAPTOR WAS IDENTIFIED AS AN UNAPPROVED/SUPPORTED/SUPPLIED ADAPTOR USED BY THE COMPLAINANT.

    Description of Event or Problem · 1

    IT WAS REPORTED ON (B)(6) 2019 THAT THE CORD TO THE TABLET WAS ON FIRE. NURSE ASKED PATIENT IF THERE WERE ACTIVE SPARKS OR FIRE. PATIENT REPORTED SHE WAS UNSURE. NURSE CONFIRMED THERE WAS NO INJURY TO THE PATIENT. INSTALLER RETURNED TO THE PATIENT HOME ON (B)(6) 2020 TO RETRIEVE THE CORD AND TABLET AND SUBSEQUENTLY RETURNED THE ENTIRE KIT INCLUDING THE ECAD BP, SPO2, AND THE SCALE WHICH IS THE ENTIRE KIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    82671 SAMSUNG N/A MSX VISICU, INC - DUP SAMSUNG TAB E SM-T377A NA 00884838084452

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Female Other