Description of Event or Problem · 0
THE CUBBY BED SENSORY BED IS A PROBLEM. THERE ARE MULTIPLE SERIOUS REPORTED SAFETY EVENTS ON RECORD TO THE FDA. THESE INCLUDED THE DEATHS OF AT LEAST 2 CHILDREN DUE TO ASPHYXIATION, AND THE MANUFACTURER MADE A RECALL AND CORRECTION. THEREAFTER, EVERY YEAR SINCE 2023 THERE HAS BEEN AN ASTRONOMICAL INCREASE IN REPORTED EVENTS EVERY YEAR INCLUDING SERIOUS INJURIES SUCH AS A CHILD WHO USED THE DEVICE TO JUMP/FALL OUT OF A 2ND STORY WINDOW, MANY CHILDREN WHO HAVE BEEN ENTRAPPED (AND AT RISK OF INJURY OR ASPHYXIATION) IN PARTS OF THE BED DUE TO BED MATERIAL MALFUNCTIONS, A CHILD WITH A KNEE DISLOCATION FROM GETTING CAUGHT IN BED PARTS THAT MALFUNCTIONED, AND MANY MANY CHILDREN WHO HAVE ELOPED FROM THE BED DUE TO MATERIAL MALFUNCTIONS. THE BED DOES NOT MEET THE DEFINITION OF DURABLE MEDICAL EQUIPMENT BECAUSE IT IS NOT DURABLE FOR AT LEAST 3 YEARS FOR USE, AND IS NOT SAFE FOR USE IN THE HOME SETTING. THE ONE THING THE BED IS SUPPOSED TO PREVENT, ELOPEMENT, IT IS NOT SUCCESSFUL AT. THIS MANUFACTURER CONTINUES TO ADVERTISE THESE BEDS FOR CHILDREN WITH AUTISM AND SPECIAL NEEDS, AND THE GOVERNMENT PAYS FOR THEM THROUGH MEDICAID (IN SOME STATES, AS HIGH AS $15 TO 20,000). THE COST IS ASTRONOMICAL, THE GOVERNMENT IS PAYING FOR THEM, AND THE PRODUCT AT BEST IS UNSAFE AND DOESN'T WORK. PATIENT CODE: 4461;1762;2327;1848;2374;4581. DEVICE CODE: 2588;1420;1384;2978;3191. REFERENCE REPORT: MW5188401.