FDA Adverse Event Other Summary report: N

GOLDEN CHAMPION 4 MOTORIZED SCOOTER

MDR report key: 2949488 · Received February 4, 2013

Report

Report Number
MW5028883
Event Type
Other
Date Received
February 4, 2013
Date of Event
December 31, 2012
Product Code
INI
Report Source
Voluntary report
Reporter Location
CA, US
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

THE SUBJECT SCOOTER HAS A VERY INTERESTING FEATURE THAT (B)(6) AND THE MFR IS FULLY AWARE OF. NEITHER PARTY THINKS THERE IS A SAFETY ISSUE. I TOTALLY DISAGREE WITH THIS STAND AND FEEL AN INVESTIGATION SHOULD BE STARTED IMMEDIATELY!!! WHAT OCCURS WITH THIS PARTICULAR SCOOTER IS THAT THE ENTIRE SEAT ASSEMBLY IS NOT HELD IN PLACE AT ALL. THIS MEANS THE SEAT ASSEMBLY CAN FALL OFF THE SCOOTER AT ANY TIME AND WHILE NOT AFFECTING ME, IT CAN CAUSE A PILE-UP WITH VEHICLES BEHIND ME. THE SEAT IS NOT SMALL AND WEIGHS, I'M GUESSING APPROXIMATELY 50LBS. BESIDES A PILE-UP, IT COULD CAUSE SERIOUS DAMAGE TO A VEHICLE AND ITS PASSENGERS. THIS WOULD BE SIMILAR TO A CAR LOSING A HUB CAP OR A MUFFLER. AS JUST STATED, IT'S AN ISSUE OF THE VEHICLE ITSELF BUT MUCH THE ISSUE OF EVERYBODY BEHIND IT TRYING TO AVOID THE FLYING DEBRIS. THE COMPANY THAT DOES THE REPAIR WORK ON THE (B)(6) SCOOTERS AND WHEELCHAIRS IS (B)(6) AND THEIR PHONE/FAX NUMBERS ARE (B)(6), RESPECTIVELY. THEY CALLED THE MFR AND WERE TOLD THAT IS THE WAY THE SCOOTER IS DESIGNED AND THERE IS NO LOCKING FEATURE TO KEEP THE SEAT FROM FLYING OFF. "THEY CALLED THE (B)(6) ITSELF AND WERE TOLD THAT IS SCOOTER AND HAVE ME JUST USE AS-IS". I CAN SOMEWHAT UNDERSTAND THE MFR'S DECISION WHICH IS MAKE MORE MONEY BY CUTTING CORNERS. HOWEVER, THE (B)(6) ACTIONS ARE A WHOLE DIFFERENT SITUATION. WHEN YOU CALL (B)(6), THE FIRST THING THAT IS SAID ON THEIR RECORDINGS IS "(B)(4)". I GUESS THAT IS MORE TALK THAN ACTION... HOW THEY CAN KNOWINGLY GIVE A (B)(6) A PRODUCT THEY KNOW COULD BE POTENTIALLY DANGEROUS IS BEYOND ME. I'M NOT ASKING THAT (B)(6) NO LONGER USE THIS VENDOR BUT STOP ORDERING THE SCOOTERS FROM THEM UNTIL A FIX IS FOUND ON MY SCOOTER, AS WELL AS OTHER SCOOTERS SOLD TO (B)(6). I KNOW THAT YOUR IMPORTANT AGENCY ISN'T STAFFED AS WELL AS IT SHOULD BE BUT HOPEFULLY SOMEONE CAN LOOK INTO THIS PROBLEM. (B)(6). I WOULD APPRECIATE A PROMPT RESPONSE TO THE ABOVE. (B)(6).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
47203 GOLDEN CHAMPION 4 MOTORIZED SCOOTER NONE INI

Patients

Seq Age Sex Outcome Treatment
1