BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WITT BIOMEDICAL CORP

    MDR report key: 313803 · Received January 15, 2001

    Report

    Report Number
    MW1020906
    Event Type
    Malfunction
    Date Received
    January 15, 2001
    Date of Event
    December 1, 2000
    Report Date
    January 15, 2001
    Manufacturer
    WITT BIOMEDICAL CORP.
    Product Code
    MHX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE SPO2 STOPPED WORKING. RPTR WORKED WITH WITT TECH SUPPORT OVER THE PHONE. THEY SENT A NEW VERSION E S4 BOARD. THE UPGRADED S4 BOARD HAS FUSES ON THE 15 VOLT POWER SUPPLIES TO PROTECT THE SYSTEM IF POWER SUPPLIES SHORT. OLD S4 BOARD (NO FUSES) HAD A SHORTED POWER SUPPLY. THE BOARD HAD HIGH CURRENT DRAW AND BURNED UP THREE CONTACTS ON THE MAIN MOTHERBOARD. IF THE CONTACTS DID NOT BURN UP THE BOARD COULD HAVE STARTED A FIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1719 WITT BIOMEDICAL CORP PATIENT MONITOR MHX WITT BIOMEDICAL CORP. SERIES IV NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA