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Patient 1
THE END-USER REPORTED THEY HAD JUST COME TO THE BOTTOM OF THE RAMP THAT LEADS FROM THEIR HOME TO AN OUTDOOR SCREENED PORCH WHEN THE DEVICE REPORTEDLY CONTINUED TO DRIVE. THE END-USER CLAIMED THEY HAD REMOVED THEIR HAND FROM THE JOYSTICK, BUT THE DEVICE CONTINUED TO DRIVE UNTIL IT IMPACTED WITH THE ALUMINUM SIDING OF THE SCREENED ROOM. REPORT CLAIMED THE END-USER HAD RE-INJURED A TOE ON THEIR LEFT FOOT WHICH HAD BEEN BROKEN PREVIOUSLY FROM AN SIMILAR INCIDENT APPROXIMATELY 2 WEEKS PRIOR. THE PREVIOUS EVENT WAS NEVER REPORTED TO PERMOBIL, BUT DESCRIPTION OF THAT EVENT WAS IDENTICAL IN EVERY RESPECT IN THAT IT OCCURRED IN THE SAME LOCATION WITH THE SAME ALLEGATION OF CONTINUED DRIVE WITH COLLISION INTO SCREEN PORCH ALUMINUM STRUCTURE. SERVICE PROVIDER STATED THEY DID NOT REPORT THE ORIGINAL INCIDENT TO PERMOBIL AS THEY CONSIDERED THAT EVENT AS USE ERROR. PROVIDER REPORTS HAVING EVALUATED THE DEVICE FINDING NO ISSUES THAT WOULD INDICATE A PRODUCT MALFUNCTION HAVING OCCURRED. AFTER RECEIVING A SECOND REPORT OF FAILURE TO STOP, PERMOBIL WAS NOTIFIED. THE DEVICE WAS RE-EVALUATED AFTER THE SECOND REPORTED EVENT TO WHICH THE DEVICE WAS AGAIN FOUND TO BE FULLY OPERATIONAL WITH THE DEVICE COMING TO A FULL AND COMPLETE STOP EACH TIME THE JOYSTICK WAS RELEASED. MULTIPLE ATTEMPTS TO RECREATE THE REPORTED ANOMALY WERE CONDUCTED TO WHICH THE DEVICE OPERATED NORMALLY WITHOUT ANY DEVIATION OR HESITATION IN DRIVE CONTROLS. NO REPORTS WERE RELAYED TO THE PROVIDER OF THE DEVICE HAVING OPERATED ABNORMALLY, IN ANY OTHER SITUATION OR LOCATION, OTHER THAN THE 2 INSTANCES REPORTED HAVING OCCURRED AT THE SAME LOCATION. THE DEVICE WAS INSPECTED AND FOUND TO BE IN PROPER WORKING CONDITION WITH NO NOTABLE DEFICIENCIES. THE DHR WAS REVIEWED AND THE DEVICE MET SPECIFICATION PRIOR TO DISTRIBUTION.