AERO T
Received Aug 27, 2018 · Event occurred Jul 31, 2018
Report 3032618-2018-00005 · MDR key 7820451
Device
Product problems
- Break
- Break
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
NO INJURY WAS REPORTED IN THIS EVENT. THERE IS A RISK OF SERIOUS INJURY IN THE CASE OF A FAILURE OF THE ANTI-TIPS WHILE ENGAGED. THE RETURNED SAMPLES OF THE ANTI-TIPS WERE TESTED, ALONG WITH SAMPLES FROM THE THEN-CURRENT LOT AND OF A DIFFERENT LOT. THE RESULTS OF A COMBINATION OF INTERNAL AND EXTERNAL/THIRD-PARTY TESTING INDICATES THAT THE MATERIAL OF THE ANTI-TIP TUBE USED ON THE CONSTRUCTION OF THIS CHAIR WAS SOFTER AND WEAKER THAN THE DESIGN SPECIFIED.
Description of Event or Problem
THE PROVIDER CLAIMS THAT THEY WERE PERFORMING AN ANTI-TIP CHECK THAT THEY DO WITH EVERY CLIENT BY HAVING THE USER LEAN BACK ON THE ANTI-TIPS TO MAKE SURE THE FRONT CASTERS ARE NOT MORE THAN 4" OFF THE GROUND; THIS TEST IS PERFORMED ON A LEVEL SURFACE. WHILE THEY DID THIS CHECK, THE TECH NOTICED THE ANTI-TIP EXTENSIONS WERE BEGINNING TO BEND. THE TECH CLAIMS THAT BEFORE THIS TEST, HE ADJUSTED THE CENTER OF GRAVITY AS FAR BACK AS HE COULD, AND TRIED TO CHANGE THE POSITION WHERE THE ANTI-TIP WAS MOUNTED.
Remedial action
- Replace