AERO T

Additional Manufacturer Narrative

THE INJURIES REPORTED IN THIS CASE WERE NOT CONSIDERED TO BE SERIOUS, HOWEVER THERE IS A RISK OF SERIOUS INJURY IN THE CASE OF A FAILURE OF 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 IN THE CONSTRUCTION OF THIS CHAIR WAS SOFTER AND WEAKER THAN THE DESIGN SPECIFIED.

Description of Event or Problem

THE PROVIDER TOOK THE END USER IN THEIR NEW WHEELCHAIR OUT TO THE PARKING LOT OF THE HOSPITAL WHERE THE END USER PROPELLED THEMSELVES UP A SLIGHT INCLINE. ALLEGEDLY DURING THIS TIME, THE CHAIR ROCKED BACKWARDS AND CONTACTED THE ANTI-TIPS THREE TIMES, WHERE ON THE THIRD TIME THE ANTI-TIP TUBES FAILED AND THE CHAIR FELL BACKWARDS. THE PROVIDER CLAIMS THAT THE END USER HIT HIS HEAD AND A CT WAS DONE, BUT THAT SO FAR, HE IS OKAY.