UNKNOWN

Additional Manufacturer Narrative

THE LEGAL DOCUMENT RECEIVED BY INVACARE INDICATED THAT INVACARE IS THE MANUFACTURER OF THE LAP BELT. INVACARE WAS NOT LISTED AT THE MANUFACTURER OF THE WHEELCHAIR THE SUBJECT LAP BELT WAS INSTALLED ON. THE MODEL NUMBER OF THE LAP BELT WAS NOT PROVIDED. FOR FILING PURPOSES, TAYLOR STREET MANUFACTURING (ELYRIA, OHIO) CFN NUMBER IS BEING UTILIZED FOR THIS MEDWATCH. THE LEGAL DOCUMENT ADVISED A CAMERA WAS INSTALLED IN THE END-USER¿S ROOM WHICH PROVIDED A LIVE AUDIO/VIDEO FEED TO THE MONITORING STATION AT THE FACILITY THE END-USER LIVED AT. THERE HAD BEEN NO FACILITY EMPLOYEE AT THE MONITORING STATION DURING THE TIME OF THE INCIDENT. FURTHERMORE, IT WAS STATED THE FACILITY FAILED TO CHECK ON THE END-USER EVERY HOUR AS REQUIRED. THERE WAS NO INDICATION OF ANY MALFUNCTION OR DEFICIENCY OF THE LAP BELT. ATTEMPTS ARE ONGOING TO OBTAIN ADDITIONAL INFORMATION REGARDING THIS INCIDENT WHICH INCLUDES MODEL NUMBER OF THE LAP BELT AND MODEL OF THE WHEELCHAIR THE LAP BELT WAS INSTALLED ON. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP MEDWATCH WILL BE FILED.

Description of Event or Problem

A LEGAL DOCUMENT WAS RECEIVED ALLEGING AN INCIDENT OCCURRED ON (B)(6) 2023. THE DOCUMENT STATES THE END-USER WAS SITTING IN HER WHEELCHAIR IN THE LIVING SPACE OF HER ROOM AT THE FACILITY. SHE WAS SLIGHTLY RECLINED IN THE WHEELCHAIR AND HAD A LAP BELT SECURED BY VELCRO POSITIONED ACROSS HER LAP. THE END-USER WAS LEFT ALONE IN HER ROOM. OVER THE NEXT TWO HOURS, THE END-USER BEGAN TO SLOWLY SLIDE FROM THE SEATED POSITION IN HER WHEELCHAIR TO THE GROUND. THE LAP BELT THAT WAS INITIALLY ATTACHED ACROSS HER HIPS, BECAME TIGHTER AROUND HER ABDOMEN, CHEST AND FINALLY HER NECK. SHE WAS STRANGLED AND DIED OF ASPHYXIATION.