BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOKIA LUMIA 1020 (GOCHECK KIDS MOBILE APP INSTALLED) PRODUCT CODE INCORRECT N/A

    MDR report key: 7868548 · Received September 12, 2018

    Report

    Report Number
    3010539401-2018-00001
    Event Type
    Malfunction
    Date Received
    September 12, 2018
    Date of Event
    June 28, 2018
    Report Date
    August 29, 2018
    Manufacturer
    ORIGINAL MANUFACTURER NOKIA OUT OF BUSINESS
    Product Code
    HLM
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE RETURNED TO MANUFACTURER: TO CLARIFY, THIS IS THE DATE THAT THE DEVICE WAS RETURNED TO GOBIQUITY, NOT THE DATE IT WAS RETURNED TO NOKIA. AS EXPLAINED, THIS WAS A COMPLAINT REGARDING THE PHONE, VERSUS THE APP THAT IS INSTALLED ON THE PHONE. AS SUCH, NOKIA, THE ORIGINAL MANUFACTURER OF THE DEVICE IS UNABLE TO RECEIVE THE PHONE FOR EVALUATION AS THEY ARE NO LONGER IN BUSINESS.

    Description of Event or Problem · 1

    THE USER NOTIFIED US INDICATING THAT WHEN THEY CAME INTO THE OFFICE, AFTER CHARGING THE SMARTPHONE (NOKIA 1020) WITH THE GOCHECKKIDS APP INSTALLED OVERNIGHT, THE OFFICE SMELLED LIKE SOMETHING MAY HAVE BURNED. THEY FOUND THE SMARTPHONE IN A DISABLED STATE, UNABLE TO TURN ON, AND THE PLASTIC CASE AROUND THE CHARGER HAD MELTED WHERE THE CHARGER CONNECTS TO THE PHONE. THERE WAS NO USER INJURY, NO PATIENT INVOLVEMENT AND NO FACILITY DAMAGE. THE DEVICE WAS RETURNED AND CAPA (B)(4) WAS INITIATED. EVALUATION OF THE DEVICE UNDER CAPA (B)(4) REVEALED THAT THE CONNECTION BETWEEN THE MICRO USB CHARGER AND CHARGING PORT ON THE NOKIA 1020 WERE DAMAGED MOST LIKELY FROM MIS-USE, FORCING OF THE CHARGER INTO THE CHARGING PORT, OR BY NOT FOLLOWING DIRECTIONS ON HOW TO PROPERLY CONNECT THE CHARGER TO THE PHONE. IT WAS DETERMINED THAT UNDER THE MIS-USE CONDITION OF CHARGER NOT PROPERLY FITTING INTO CONNECTOR, THE DEVICE OVERHEATED. THE DEVICE ALSO FUNCTIONED PROPERLY UNDER THE OVERHEATING CONDITION IN THAT THE OVERHEATING CAUSED THE SOLDER JOINT TO MELT, WHICH RENDERS THE DEVICE INOPERABLE BY SHUTTING THE DEVICE DOWN, THUS PREVENTING ANY FURTHER DAMAGE OR USE. REGARDLESS, WE DETERMINED THIS TO BE REPORTABLE AS IF IT WERE TO RECUR, IT MAY CAUSE INJURY, EVEN THOUGH IT IS VERY UNLIKELY, SINCE THE DEVICE PERFORMED AS SPECIFIED. WE ARE UNABLE TO RETURN THE DEVICE TO THE ORIGINAL MANUFACTURER (NOKIA), AS NOKIA SOLD THE ASSET TO MICROSOFT, AND IN 2015, MICROSOFT TOOK A (B)(4) WRITE-DOWN ON THE NOKIA PURCHASE, AND ANNOUNCED LAYOFFS OF 7,800 EMPLOYEES, PRIMARILY WITHIN MICROSOFT'S PHONE BUSINESS. IN MAY 2016, MICROSOFT GUTTED ITS MOBILE BUSINESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    708572 NOKIA LUMIA 1020 (GOCHECK KIDS MOBILE APP INSTALLED) PRODUCT CODE INCORRECT N/A SMART PHONE HLM ORIGINAL MANUFACTURER NOKIA OUT OF BUSINESS LUMIA 1020

    Patients

    Seq Age Sex Outcome Treatment
    1 1 YR