BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONITOR,BP,SPO2,ORAL TEMP

    MDR report key: 13725539 · Received March 10, 2022

    Report

    Report Number
    1417592-2022-00028
    Event Type
    Malfunction
    Date Received
    March 10, 2022
    Date of Event
    December 3, 2021
    Report Date
    May 20, 2022
    Manufacturer
    EDAN INSTRUMENTS INC
    Product Code
    DQA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED BY THE CUSTOMER THAT SMOKE IS COMING FROM THE UNIT WHERE THE POWER CORD GETS ATTACHED TO THE UNIT. PER THE CUSTOMER THE PATIENT WAS NOT CONNECTED AT THE TIME THE SMOKE WAS NOTED, THE DEVICE WAS CHARGING WITH ITS ORIGINAL CORD. THE SAMPLE WAS RETURNED FOR EVALUATION AND THE CUSTOMER REPORTED ISSUE WAS CONFIRMED. THE SAMPLE WAS CONFIRMED TO HAVE BURN MARK ON THE UNITS PCB BOARD. FUNCTIONAL TESTING WAS PERFORMED AND THE DEVICE PASSED SPO2, NIBP, AND TEMPERATURE TESTS. A DEFINITIVE ROOT CASE COULD NOT BE DETERMINED AT THIS TIME. DUE TO THE REPORTED INCIDENT AND IN AN ABUNDANCE OF CAUTION, THIS MEDWATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    D.3 UPDATED MANUFACTURERS INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT SMOKE IS COMING FROM THE UNIT WHERE THE POWER CORD GETS ATTACHED TO THE UNIT. PER THE CUSTOMER THE PATIENT WAS NOT CONNECTED AT THE TIME THE SMOKE WAS NOTED, THE DEVICE WAS CHARGING WITH ITS ORIGINAL CORD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    605546 MONITOR,BP,SPO2,ORAL TEMP DQA EDAN INSTRUMENTS INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown