BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVAPLUS DIGITAL THERMOMETER

    MDR report key: 9859709 · Received March 20, 2020

    Report

    Report Number
    9859709
    Event Type
    Malfunction
    Date Received
    March 20, 2020
    Date of Event
    January 18, 2020
    Report Date
    March 3, 2020
    Manufacturer
    EKLA CORPORATION
    Product Code
    FLL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    RN OBTAINED RECTAL TEMPERATURE ON PEDIATRIC PATIENT MULTIPLE TIMES IN INITIAL 4 HOURS OF SHIFT. PATIENT TEMPERATURE READ 98.6 OR 98.7 EACH TIME. PATIENT HAS HAVING DIFFICULTY BREATHING AND FELT WARM TO THE TOUCH. RN ATTEMPTED AN ALTERNATIVE ROUTE AND UTILIZED TEMPORAL THERMOMETER WHICH READ 100.4. NEW RECTAL THERMOMETER OBTAINED AND TEMPERATURE READ 100.0. MANUFACTURER RESPONSE FOR DIGITAL THERMOMETER, NOVAPLUS DIGITAL THERMOMETER (PER EKLA SITE REPORTER). CUSTOMER SERVICE (B)(4) NOTIFIED OF EQUIPMENT FAILURE. IT APPEARED THE LOT NUMBER WAS EXPIRED. AT THE REQUEST OF EKLA, I VERIFIED THAT WE DID NOT HAVE ANOTHER THERMOMETER OF THE SAME LOT NUMBER ON OUR SHELF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324251 NOVAPLUS DIGITAL THERMOMETER DIGITAL THERMOMETER FLL EKLA CORPORATION 20151230

    Patients

    Seq Age Sex Outcome Treatment
    1 42 DA