inforMED
MalfunctionHLM

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

Received Sep 12, 2018 · Event occurred Jun 28, 2018

Report 3010539401-2018-00001 · MDR key 7868548

Device

Generic name

Smart Phone

Model number

LUMIA 1020

Product problems

  • Improper or Incorrect Procedure or Method
  • Improper or Incorrect Procedure or Method

Patient

1 YR

  • No Consequences Or Impact To Patient
  • No Consequences Or Impact To Patient

Narrative

Additional Manufacturer Narrative

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

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.

Remedial action

  • Replace