MAUDE Adverse Event Report: SMARTMISSIMO TECHNOLOGIES PTE LTD POWERDOT; POWERED MUSCLE STIMULATOR

Model Number POWERDOT 2.0

Device Problem Overheating of Device (1437)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/12/2020

Event Type  malfunction  

Manufacturer Narrative

The complaint device was returned for evaluation.The reported event was confirmed; melting of the device at the usb charger connection point was observed.The initial device evaluation identified that the unit was heavily coated with an oily substance, confirmed by the patient to be an arthritic cream, voltaren.The substance was observed on all cables and within the pins of the male (device) end of the cable.Inspection of the usb socket soldering point, the battery, and the pcb did not identify defects or evidence of a short circuit that would cause overheating.The presence of a conductive foreign substance within the pins of usb charging cable could cause a short circuit resulting in high heat generation during the charging process.Therefore, the event is suspected to be caused by the patients use of a foreign substance while handling the device resulting in overheating.Product labeling already warns against allowing foreign substances to get into the device.This type of event will continue to be monitored.

Event Description

The patient reported that during use, the unit stimulation was "cutting off".The patient reported that he thought the issue was due to the device needing to be charged.The patient charged the device and minutes after plugging in to charge, the patient smelled an electrical smell and observed the device plastic melting at the usb port.When the patient disconnected the usb cable from the device, the device usb port disconnected from the device.The patient provided photos via email.The patient reported that there was no injury or damage to property.

• Brand Name: POWERDOT
• Type of Device: POWERED MUSCLE STIMULATOR
• Manufacturer (Section D): SMARTMISSIMO TECHNOLOGIES PTE LTD; 4 shenton way, #28-01 sgx cent; singapore central singapore, 06880 7; SN 068807
• Manufacturer (Section G): ZMI ELECTRONICS, LTD.; 6f-1, no. 286-4, shin ya rd; kaohsiung, 806 ; TW 806
• Manufacturer Contact: gabriela mccoole ; 4 shenton way, #28-01 sgx cent; singapore central singapore, 06880-7 ; SN 068807
• MDR Report Key: 10240291
• MDR Text Key: 231408865
• Report Number: 3012282682-2020-00001
• Device Sequence Number: 1
• Product Code: NGX
• UDI-Device Identifier: 14719872330387
• UDI-Public: (01)14719872330387(11)191115(10)1902-24413
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172876
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: POWERDOT 2.0
• Device Catalogue Number: DUOBLACK2
• Device Lot Number: 1902
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2020
• Device Age: 3 MO
• Initial Date Manufacturer Received: 06/18/2020
• Initial Date FDA Received: 07/07/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/27/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1