BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIGITAL THERMOMETER

    MDR report key: 1050067 · Received May 13, 2008

    Report

    Report Number
    1050067
    Event Type
    Malfunction
    Date Received
    May 13, 2008
    Date of Event
    April 29, 2008
    Report Date
    May 13, 2008
    Manufacturer
    K-JUMP HEALTH CO., LTD
    Product Code
    FLL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PARENTS OF INFANT USED CVS BRAND DIGITAL THERMOMETER AT HOME TO CHECK CHILD'S TEMPERATURE. TEMPERATURE READ AS 102.5. FAMILY PRESENTED TO ER WITH INFANT. IN ER SETTING TEMPERATURE OBTAINED WAS 98.9. SEPSIS WORK-UP PERFORMED, INCLUDING MULTIPLE LUMBAR PUNCTURE ATTEMPTS. IV ANTIBIOTICS ADMINISTERED. PARENTS BROUGHT THERMOMETER IN FROM HOME. WHEN TESTED, THE INFANT TEMPERATURE WAS 103 ON THE CVS THERMOMETER AND 99.2 ON THE HOPSITAL THERMOMETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIGITAL THERMOMETER THERMOMETER, DIGITAL FLL K-JUMP HEALTH CO., LTD KD-192 *

    Patients

    Seq Age Sex Outcome Treatment
    1 12 DAY