MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-12 for NOKIA LUMIA 1020 (GOCHECK KIDS MOBILE APP INSTALLED) PRODUCT CODE INCORRECT N/A manufactured by Original Manufacturer Nokia Out Of Business.
[120265578]
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.
Patient Sequence No: 1, Text Type: N, H10
[120265579]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010539401-2018-00001 |
| MDR Report Key | 7868548 |
| Date Received | 2018-09-12 |
| Date of Report | 2018-08-29 |
| Date of Event | 2018-06-28 |
| Date Mfgr Received | 2018-06-28 |
| Device Manufacturer Date | 2016-05-18 |
| Date Added to Maude | 2018-09-12 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | DARCY WENDEL |
| Manufacturer Street | 7135 E CAMELBACK RD, SUITE 360 |
| Manufacturer City | SCOTTSDALE AZ 852511289 |
| Manufacturer Country | US |
| Manufacturer Postal | 852511289 |
| Manufacturer Phone | 3238423963 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | NOKIA LUMIA 1020 (GOCHECK KIDS MOBILE APP INSTALLED) PRODUCT CODE INCORRECT N/A |
| Generic Name | SMART PHONE |
| Product Code | HLM |
| Date Received | 2018-09-12 |
| Returned To Mfg | 2018-09-10 |
| Model Number | LUMIA 1020 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ORIGINAL MANUFACTURER NOKIA OUT OF BUSINESS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-09-12 |