BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARC INSTATEMP DIGITAL NON-TOUCH FOREHEAD THERMOMETER

    MDR report key: 8350801 · Received February 19, 2019

    Report

    Report Number
    MW5084157
    Event Type
    Malfunction
    Date Received
    February 19, 2019
    Date of Event
    February 6, 2019
    Report Date
    February 7, 2019
    Manufacturer
    ARC DEVICES USA, INC.
    Product Code
    FLL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    THE SUBMITTER IS REPORTING THE UNIT FOR POSING A FIRE AND INJURY HAZARD. HE HEARD A LOUD NOISE AND WHEN HE WENT INTO HIS CHILD¿S ROOM HE NOTICED PIECES OF THE UNIT ACROSS THE FLOOR. HE INDICATED THAT THE UNIT WAS ON THE CHANGING TABLE AND HE NOTICED BATTERY ACID HAD SPATTERED OVER THE CHANGING TABLE AND HIS CHILD¿S BLANKETS NEARBY. HE SAID THE UNIT WAS NOT BEING USED WHEN THE INCIDENT OCCURRED. HE INDICATED THAT THE BATTERIES CAME WITH THE UNIT. THE SUBMITTER¿S WIFE CONTACTED THE FIRM AND REPORTED THE INCIDENT. THE FIRM TOLD HER THE UNIT WAS A 2015 MODEL AND THAT THE BATTERIES WERE OLD, WHICH MAY HAVE CAUSED THE INCIDENT. THE FIRM HAS OFFERED A REFUND. THE SUBMITTER BELIEVES THE PRODUCT SHOULD BE INVESTIGATED TO PREVENT INJURIES TO AN INFANT. HE¿S CONCERNED THAT AN INCIDENT CAN OCCUR WHILE A PARENT USES THE UNIT ON THEIR CHILD. PRODUCT CATEGORY: BABY; PRODUCT TYPE: NURSERY EQUIPMENT & SUPPLIES; RETAILER: (B)(6); PURCHASE DATE: 9/1/2018, THIS DATE IS AN ESTIMATE. THE PRODUCT WAS DAMAGED BEFORE THE INCIDENT: NO. THE PRODUCT WAS MODIFIED BEFORE THE INCIDENT: NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144038 ARC INSTATEMP DIGITAL NON-TOUCH FOREHEAD THERMOMETER THERMOMETER, ELECTRONIC, CLINICAL FLL ARC DEVICES USA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1