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Patient 1
AS REPORTED TO FDA PER 1220762-11-15-2017-001-R, THE INVOLVED BUTTON IS PART OF A FIELD ACTION ON THE PART OF THE MANUFACTURER. THE INVOLVED BUTTON DID NOT HAVE THE APPROPRIATE FALL PARAMETERS. IT IS UNCLEAR FROM THE INFORMATION PROVIDED TO THE MANUFACTURER IF THE BUTTON MAY HAVE CONTRIBUTED TO ANY INJURY THE SUBSCRIBER SUSTAINED. THE INVOLVED BUTTON WAS STILL ABLE TO BE DEPRESSED TO SUMMON HELP. PER AUTOALERT HELP BUTTON, INSTRUCTIONS FOR USE (P/N 0940718 REV. 7) P. 10 THE AUTOALERT HELP BUTTON CAN DETECT MOST FALLS, PROVIDING AN ADDED LAYER OF PROTECTION. IF YOU THINK YOU NEED ASSISTANCE, PUSH YOUR HELP BUTTON IMMEDIATELY TO INITIATE THE HELP CALL. PUSHING THE HELP BUTTON GENERATES THE HELP CALL IMMEDIATELY. P. 13 RECOMMENDED USAGE PUSH YOUR AUTOALERT HELP BUTTON ANY TIME YOU NEED HELP. IF YOU FALL AND ARE ABLE TO, YOU SHOULD STILL PUSH THE AUTOALERT BUTTON TO SEND A HELP CALL RIGHT AWAY. PER AUTOALERT HELP BUTTON, INSTRUCTIONS FOR USE, P/N 0940718 REV. 7 P. 5 STATES: "IN CERTAIN SITUATIONS, THE AUTOALERT HELP BUTTON MAY NOT DETECT A FALL. SOME MOVEMENTS MAY NOT REGISTER AS A FALL AND WOULD NOT BE DETECTED. EXAMPLES INCLUDE, BUT ARE NOT LIMITED TO: A GRADUAL SLIDE SUCH AS FROM A SEATED POSITION; LOWERING ONESELF SLOWLY TO THE GROUND (TO BRACE THE IMPACT OF A FALL) , A FALL FROM A HEIGHT OF LESS THAN 20 INCHES (0.5 METERS)."