Description of Event or Problem · 0
NEOBLUE PHOTOTHERAPY LIGHT BY NATUS, SN (B)(4), EXPERIENCED SIMULTANEOUS FAILURE OF BOTH SCREW-DEVICES THAT ARE INTENDED TO SECURE THE 12 LB PHOTOTHERAPY LIGHT AND ARM TO THE MOUNTING POLE FROM THE SAME MANUFACTURER, RESULTING IN THE ENTIRE LIGHT/ARM MECHANISM TO FALL TO THE GROUND. FORTUITOUSLY THE LIGHT HAD JUST BEEN WHEELED AWAY FROM THE PATIENT BEDSIDE, AND WHILE IT CAUSED SIGNIFICANT ENOUGH INJURY TO THE STAFF PERSON WHO'S FOOT WAS RIGHT BELOW THE FALLING DEVICE TO REQUIRE EMERGENCY MEDICAL TREATMENT, IT DID NOT COME IN CONTACT WITH THE PATIENT. THERE WAS NO WARNING THAT THE SCREWS WERE GOING TO FAIL, AND THERE WAS NO WARNING THE DEVICE WAS GOING TO FALL. HAD THIS FALLEN ON TOP OF A BABY, IT HAD POTENTIAL TO CAUSE A LETHAL INJURY OR TEMPORARY OR PERMANENT BODILY HARM. I AM INCLUDING THREE PICTURES OF THIS DEVICE, INCLUDING THE SERIAL NUMBER AND THE SCREWS/STAND TOP. UPON FURTHER INSPECTION OF OTHER SIMILAR DEVICES IN USE, WE FOUND AT LEAST ONE OTHER THAT WAS COMPLETELY MISSING ONE OF THE TWO SECUREMENT SCREWS. WE ALSO OBSERVED THAT THE ARM THAT SUPPORTS THE SECOND DEVICE WAS VERY BENT AND NOT STABLE. THE DEVICE WAS IMMEDIATELY REMOVED FROM USE. I AM INCLUDING THREE PICTURES OF THIS SECOND DEVICE (THEY ARE THE ONES WITH THE BLUE TINT SINCE THE LIGHT WAS IN USE AT THE TIME OF DISCOVERY) OUR OVERALL CONCERN IS THAT BOTH SCREWS ON THIS MEDICAL DEVICE FAILED SIMULTANEOUSLY AND THE DEVICE FELL FROM THE STAND. THE WAY THIS DEVICE IS USED, IT IS TYPICALLY POSITIONED IMMEDIATELY OVER A NEWBORN AND COULD FALL ONTO AND CRUSH THE BABY. FORTUNATELY THAT DID NOT HAPPEN TODAY. AT THIS TIME WE HAVE THE DEVICE AND BOTH OF THE SCREW THAT FAILED SEQUESTERED AND HAVE REACHED OUT TO NATUS, THE MANUFACTURER, FOR FURTHER DIRECTION. WE BELIEVE THAT THIS COULD HAPPEN AGAIN WITH A WORSE OUTCOME AND NEED TO UNDERSTAND HOW WE CAN BE ASSURED THAT THE SCREWS THAT HOLD THIS DEVICE TOGETHER WILL NOT FAIL AGAIN IN THE FUTURE. FDA SAFETY REPORT ID # (B)(4).