THE ASC INDICATED THAT THE COMPLAINANT INITIALLY REPORTED THAT THE MOUNTING BRACKET OF THE NEOBLUE 3 UNIT WAS BROKEN BECAUSE THEY MISTAKENLY BELIEVED THAT THE THUMBSCREWS WERE FIXED TO THE UNIT. THEREFORE, SEEING THAT THE THUMBSCREWS WERE MISSING AFTER THE UNIT FELL LIKELY INDICATED TO THE COMPLAINANT THAT THE MOUNTING SYSTEM HAD BROKEN. HOWEVER, IT WAS CLARIFIED THAT THE USER FACILITY HAD NOT BEEN USING BOTH THUMBSCREWS TO MOUNT THE NEOBLUE 3 UNIT TO THE ROLLSTAND. BECAUSE BOTH THUMBSCREWS WERE NOT USED AND THE DEVICE WAS FOUND TO BE UNDAMAGED DURING EVALUATION, THE CAUSE OF THE ISSUE WAS ASSIGNED AS USER ERROR. THE NEOBLUE 3 USER MANUAL 022826 REV. A CONTAINS FIGURES IN SECTION 3.1 AND 3.3 THAT DEPICT TWO THUMBSCREWS INSERTED IN THE MOUNTING PLATE. THE NEOBLUE 3 SERVICE MANUAL 022821 REV. A SECTION 5.3 CONTAINS A PARTS LIST THAT SPECIFIES A QUANTITY OF TWO THUMBSCREWS (P/N 800226). FIGURES 1-2 AND 2-3 DEPICT TWO THUMBSCREWS INSERTED IN THE MOUNTING PLATE.
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Patient 1
IT WAS REPORTED VIA AN (B)(6) ADVERSE INCIDENT REPORT ((B)(4)) THAT AFTER AN HOUR OF BEING ATTACHED TO A ROLL STAND, A NEOBLUE 3 UNIT COLLAPSED AND LANDED ON TOP OF AN INCUBATOR WHICH HAD A BABY INSIDE OF IT. THE COMPLAINANT IN THE (B)(6) REPORT (AN EME MANAGER AT THE USER FACILITY) STATED "I REMOVED THE PHOTOTHERAPY UNIT FROM THE BABYS BEDSIDE AND REPLACED IT WITH ANOTHER, UPON INSPECTION THERE WAS ONLY ONE SCREW IN THE BRACKET HOLDING THE UN[IT] ONTO THE POLE." THERE HAS BEEN NO INFORMATION PROVIDED STATING THERE WAS A DEATH OR SERIOUS INJURY. PHOTOS OF THE AFFECTED NEOBLUE 3 UNIT SHOWED THAT THE MOUNTING PLATE WAS IN PLACE, AS WERE TWO LOCATING POST SCREWS. NO THUMBSCREWS WERE IN PLACE. A NATUS TECHNICAL SERVICE MANAGER COMMENTED THAT THE FOUR RIVETS OF THE MOUNTING PLATE APPEARED TO BE IN PLACE IN THE PHOTOS. A REPRESENTATIVE OF THE AUTHORIZED SERVICE CENTER (ASC) IN THE (B)(4) REPORTED THAT THE COMPLAINANT HAD CLAIMED IN CONVERSATION THAT THE INTERNAL BRACKET HAD BROKEN OFF AND THAT THERE WERE REPORTS THE UNIT WAS MOUNTED TO THE ROLL STAND WITH THREE SCREWS (I.E. TWO LOCATING POST SCREWS AND ONE THUMBSCREW) INSTEAD OF FOUR. UPON REQUEST OF NATUS QUALITY ASSURANCE, THE NEOBLUE 3 UNIT WAS RETURNED TO THE ASC. REGARDING THE RETURNED NEOBLUE 3, THE ASC STATED, "WE HAVE NOT OPENED IT BUT THE MOUNTING PLATE IS IN PLACE AS ARE THE RIVETS. THERE IS NOTHING WRONG." THE COMPLAINANT THEN INFORMED THE ASC THAT AT THE TIME OF THE EVENT, THEY HAD THOUGHT THAT THE THUMB SCREWS WERE FIXED LIKE THE LOCATING POST SCREWS WERE. THE ASC ADVISED THE COMPLAINANT THAT THE THUMBSCREWS ARE NOT FIXED. THE ASC INDICATED TO NATUS THAT THE USER APPEARS TO BE MOUNTING THE NEOBLUE 3 UNIT WITHOUT THE THUMB SCREWS INSERTED.