Description of Event or Problem · 1
HERE IS AN EMAIL I WROTE TO THE MEDICAL DEVICE DURABLE GOODS VENDOR: EMAIL DATE: 01/06/2020, DATE OF PROBLEM: (B)(6) 2020, PRODUCT: MAX MOBILITY SMARTDRIVE MX2+: A WHEELCHAIR POWER ASSIST DEVICE SERIAL # (B)(4) NATIONAL SEATING AND MOBILITY RE: SAFETY DEFECT WITH SMARTDRIVE SUPPLIED WATCH. HELLO (B)(6), I WOULD LIKE TO REPORT WHAT I BELIEVE TO BE A VERY SEROUS SAFETY ISSUE WITH THE TICWATCH SMARTWATCH WHICH WAS DELIVERED AS PART OF THE SMARTDRIVE SYSTEM FOR MY WHEELCHAIR. IN SHORT, THE WATCH CHARGER SUPPLIED WITH THE TICWATCH, WHICH IS OF COURSE THE CONTROL MECHANISM FOR THE SMARTDRIVE, IS LASER-ETCHED WITH THE TEXT "1A(MAX)" ON THE BASE. THOUGH, THERE IS NO DOCUMENTATION AT ALL SUPPLIED WITH EITHER THE TICWATCH, NOR THE SMARTDRIVE WHICH INDICATES THIS 1 AMP CHARGING LIMITATION. EVEN WORSE, PLUGGING THE WATCH CHARGE INTO A USB 3.0 COMPATIBLE POWER SOURCE CAUSES WHAT APPEARS TO BE A FAILURE IN THE LIPO (LITHIUM POLYMER) CHARGING CIRCUIT INTERNAL TO THE WATCH ITSELF. THE VERY NIGHT I RECEIVED DELIVERY OF THE NEW WATCH, I PLUGGED THE TICWATCH CHARGER INTO A USB MULTI-CHARGER AS I HAVE A PHONE, TABLET, BLUETOOTH HEADSET, AND VARIOUS OTHER USB POWERED DEVICES. ALL OF MY OTHER DEVICES, EVEN THOSE NOT LABELED AS "FAST CHARGING" CAPABLE, ARE ABLE TO SAFELY CHARGE AT THE DESIRED AMPERAGE WITH NO ISSUE. HOWEVER, UPON PLUGGING IN THE TICWATCH TO THE MULTI-CHARGER, THE CHARGING FUNCTION OF THE WATCH FAILED. A VERY BRIEF SEARCH ON (B)(6) UNCOVERED THAT THIS CHARGING ISSUE WITH THE TICWATCH IS A WELL-KNOWN PROBLEM. A (B)(6) POST INDICATED THAT THE FAILURE IS LIKELY INTERNAL TO THE CHARGER. THUS, TO MAKE THINGS SIMPLE, I WENT ON (B)(6) TO PURCHASE TWO NEW TICWATCH CHARGERS. UPON RECEIPT OF THE TWO NEW CHARGERS, I PLUGGED THE WATCH INTO ONE OF THE NEW CHARGERS AND FOUND THAT THE CHARGING FUNCTION STILL WORK NOT WORK. SURPRISED BY THIS, I NEXT USED A MULTI-METER TO TEST THE POWER OUTPUT ON THE POGO PINS OF THE ORIGINAL CHARGER AND COMPARED THE VOLTAGES TO THE SAME PINS ON THE NEWLY PURCHASED CHARGERS. THE VOLTAGES ARE IDENTICAL ON ALL 3 CHARGERS. THIS TESTING CONFIRMS THAT THE FAILURE IS NOT THE CHARGER, BUT INTERNAL CIRCUITRY OF THE TICWATCH ITSELF. BEING THAT I HAVE YEARS OF EXPERIENCE IN LIPO CHARGERS AND BATTERIES, I DID SOME MORE TESTING. I FOUND THAT YOU TWIST THE WATCH ON THE CHARGER BASE TO DISCONNECT THE POGO PINS AND THEN LET IT SNAP BACK IN PLACE MANY TIMES, ON SOME OCCASIONS, THE CHARGING FUNCTION WILL ACTUALLY ACTIVATE AND CHARGE THE WATCH SUCCESSFULLY. FROM AN ENGINEERING PERSPECTIVE, THIS BEHAVIOR CONFIRMS THAT ROOT CAUSE OF THE FAILURE IS NOT AN INTERNAL FUSE OR SAFETY MECHANISM MEANT TO PREVENT OVER AMPERAGE. INSTEAD, THIS BEHAVIOR SUGGESTS THAT DAMAGE IS TO THE LIPO CHARGING CIRCUIT ITSELF. IF THIS ASSERTION IS CORRECT AND THE LIPO CHARGING CIRCUIT INTERNAL TO THE WATCH IS DAMAGED BY SIMPLY PLUGGING IN THE USB CHARGER BASE INTO A USB POWER SOURCE CAPABLE OF SUPPLYING OVER 1 AMP, THEN THIS MAY BE A VERY SERIOUS SAFETY ISSUE WHICH COULD RESULT IN FIRE OR RELEASE OF TOXIC GAS. WITH THE VERY SERIOUS POTENTIAL RISK OF USER HARM, I WOULD SUGGEST THAT THIS ISSUE NEEDS TO BE REPORTED BOTH TO THE MFR AND THE FDA. DO YOU HAVE A PROCESS IN PLACE FOR THIS REPORTING? HOW WOULD YOU LIKE TO PROCEED. BEST REGARDS, (B)(6). FDA SAFETY REPORT ID# (B)(4).