BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHILIPS EAR THERMOMETER

    MDR report key: 7067965 · Received November 29, 2017

    Report

    Report Number
    3009181561-2017-00038
    Event Type
    Malfunction
    Date Received
    November 29, 2017
    Report Date
    October 31, 2017
    Manufacturer
    SHENZHEN DONGDIXIN TECHNOLOGY CO., LTD
    Product Code
    FLL
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN DESIGNED ACCORDING TO SAFETY STANDARDS AND IS SAFE TO USE WHEN USED ACCORDING TO THE DFU. ON (B)(6) 2017: THIS REPORT WAS SUBMITED TO THE US FDA IN ERROR, IT SHOULD NOT HAVE BEEN SUBMITTED. THE PRODUCT MANUFACTURER HAS BEEN COMMUNICATED OF THE ISSUE.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN DESIGNED ACCORDING TO SAFETY STANDARDS AND IS SAFE TO USE WHEN USED ACCORDING TO THE DFU.

    Description of Event or Problem · 1

    THE CONSUMER CLAIMS TO BE GETTING INACCURATE READINGS ON HIS DEVICE. HE HAD ENSURED THAT THE DEVICE WAS POSITIONED CORRECTLY AND THAT THERE WAS NO LOW CHARGE ON THE BATTERIES.

    Description of Event or Problem · 1

    THE CONSUMER CLAIMS TO BE GETTING INACCURATE READINGS ON HIS DEVICE. HE HAD ENSURED THAT THE DEVICE WAS POSITIONED CORRECTLY AND THAT THERE WAS NO LOW CHARGE ON THE BATTERIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    845686 PHILIPS EAR THERMOMETER EAR THERMOMETER FLL SHENZHEN DONGDIXIN TECHNOLOGY CO., LTD SCH740

    Patients

    Seq Age Sex Outcome Treatment
    1