Additional Manufacturer Narrative · 1
TYPE OF EVALUATION- FAILED PART(S) NOT RELEASED BY USER FACILITY FOR DIRECT EVALUATION. CONCLUSIONS BASED ON PHOTOGRAPHS OF PARTS AND SERVICE HISTORY. INCIDENT REPORT TEXT OF OCT. 23, 1996. PULLEY ASSEMBLY, LOCATED NEAR COLLIMATOR FOR COUNTERBALANCE OF COMPRESSION AND DECOMPRESSION OF SFD. PULLEY BRACKET IS BENT AND PULLEY WHICH IS FARTHEST AWAY FROM OPERATOR, WAS BADLY WORN AND CRACKED. WIRE ROPE THEN CAME OFF THE PULLEY, ALLOWING SFD TO DROP ON PATIENT. TABLE AT 0 DEGREE TILT. ITEMS OF DISCUSSION: THE INVESTIGATIONS TO THIS INCIDENT REPORT ARE BASED ON THE DESCRIPTION AND IN ADDITION ON THE PICTURES WHICH ARE SHOWING THE EXTENT OF THE DAMAGE ON THE EQUIPMENT. SINCE THE DEFECTIVE PARTS HAVE NOT BEEN RELEASED FOR EVALUATION A DETAILED ANALYSIS OF THIS EVENT IS NOT POSSIBLE. ACCORDING TO CO'S INTERPRETATION OF THE RECEIVED PICTURES, THIS PROBLEM OCCURRED DUE TO A MISALIGNMENT OF THE PULLEYS. THE MISALIGNMENT CAUSED A CONSTANT LATERAL PRESSURE WHICH IMPLICATED ATTRITION AND FINALLY THE BREAK OF THE PULLEY. WITHOUT THE EXAMINATION OF THE INVOLVED PULLEYS IT IS NOT DETERMINABLE, IF ALSO OTHER FACTORS MAY HAVE CONTRIBUTED TO THIS INCIDENT. WHEN A PULLEY BREAKS THE ROPE SLIDES FROM THE PULLEY, BUT GET CAUGHT BY THE AXLE, SO THAT THE SFD COULD FALL AT A MAXIMUM OF 4-6 CM. AN ABRASION WHICH LEAK TO SUCH AN INCIDENT CAN ONLY RESULT FROM A RELATIVE LONG TIME OF USE, WITHOUT THE NECESSARY CHECKS AND MAINTENANCE. IN THE OPERATING INSTRUCTIONS OF THE SIRESKOP IT IS STATED, THAT THE EQUIPMENT MUST BE CHECKED AT REGULAR INTERVALS BY SKILLED SERVICE PERSONNEL. ACCORDING TO CO'S MAINTENANCE INSTRUCTION AND CHECKS, SECTION SAFETY CHECKS, THE CHECK OF THE PULLEYS IS REQUIRED. CONCLUSION: THE CONCERNED EQUIPMENT SIRESKOP 4 HAS BEEN INSTALLED IN APRIL 1983. THE DATE OF INCIDENT WAS OCT. 16, 1996. A MAINTENANCE CONTRACT WITH SIEMENS DOES NOT EXIST. THE LACK OF MAINTENANCE AND REGULAR SAFETY CHECKS APPEARS TO HAVE CONTRIBUTED TO THIS EVENT. IN SPITE OF THIS, IT IS UNLIKELY THAT A SERIOUS INJURY WOULD RESULT IF THE EVENT WERE TO RECUR. WHEN A PULLEY BREAKS THE ROPE SLIDES FROM THE PULLEY AND WILL BE CAUGHT BY THE AXLE, THAT THE SFD COULD FALL ONLY AT A MAXIMUM OF 4-6 CM. WITH REGARD TO THIS SITE, ALL WORN PARTS MUST BE REPLACED AND A COMPLETE FUNCTION AND SAFETY CHECK HAS TO BE PERFORMED. FOR THE SAFE OPERATION OF THE UNIT THE REGULAR MAINTENANCE AND SAFETY CHECKS MUST BE FULFILLED. THIS COMPLAINT HAS BEEN CLOSED AT THE FACTORY.