BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OWLET BABY MONITOR

    MDR report key: 12711238 · Received October 27, 2021

    Report

    Report Number
    MW5104983
    Event Type
    Malfunction
    Date Received
    October 27, 2021
    Date of Event
    March 28, 2021
    Report Date
    October 25, 2021
    Manufacturer
    OWLET
    Product Code
    KNG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NH, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    WE PURCHASED AN OWLET HOPING TO BE ABLE TO MONITOR OUR BABY. THE FIRST NIGHT WAS TERRIFYING AS THE OXYGEN MONITOR KEPT SOUNDING AN ALARM INDICATING LOW OXYGEN LEVELS. IN A PANIC WE CALLED OUR PEDIATRICIAN, WHO SCOFFED AS SOON AS WE TOLD HIM THAT WE WERE USING THE OWLET. HE ADVISED US NOT TO USE IT AS HE HAD MANY COMPLAINTS LIKE THIS. HE EXPLAINED THAT BABY'S EXTREMITIES TYPICALLY HAD BAD CIRCULATION AND GIVEN THIS YOU WOULD EXPECT THE ALARM TO GO OFF. WE TRIED TO GET A REFUND FROM BOTH OWLET AND (B)(6). BOTH REFUSED TO REFUND THE (B)(6) WE PAID FOR THIS USELESS DEVICE. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1606245 OWLET BABY MONITOR MONITOR, ULTRASONIC, FETAL KNG OWLET

    Patients

    Seq Age Sex Outcome Treatment
    1 4 DA Other