BEUDAMED
    FDA Adverse Event Other Summary report: N

    MDE

    MDR report key: 150083 · Received February 20, 1998

    Report

    Report Number
    MW1013017
    Event Type
    Other
    Date Received
    February 20, 1998
    Manufacturer
    MEDICAL DATA ELECTRONICS
    Product Code
    LDD
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    BIOMEDICAL HAS DOCUMENTED A NUMBER OF INCIDENTS WITH THE MDE 300A MONITOR. MOST COMMON IS THE LOSS OF DATA ON THE SCREEN WHEN UNPLUGGED THE MONITOR FOR BATTERY USE FROM A CT TABLE TO THE GURNEY. MDE BELIEVES STATIC ELECTRICITY IS THE CAUSE OF THE PROBLEM. THEY SUGGESTED AN INTERNAL MODIFICATION TO ELIMINATE THE PROBLEM. MDE MODIFIED ONE MONITOR AND BIOMED MODIFIED THE SECOND MONITOR. BOTH MONITORS CONTINUE TO HAVE THE LOSS OF DATA PROBLEM. MDE HAS NOT OFFERED ANY OTHER SOLUTION TO THE PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MDE DEFIBRILLATOR/MONITOR LDD MEDICAL DATA ELECTRONICS 300A *

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other