KNEELING FRAME

Additional Manufacturer Narrative

GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR TABLE TOPS - 100704D0 - DEVICE FOR SPINAL SURGERY USED WITH 118010A0 - BASIS TABLE TOP,INDIVIDUAL CONFIGURATION. AS IT WAS STATED, THE INCIDENT INVOLVING AN ANESTHETIZED PATIENT OCCURRED DURING POSITIONING BEFORE SPINAL HERNIA SURGERY. THE PATIENT WAS PLACED ON THE ABDOMEN ON THE TABLE. DURING FOLDING DOWN OF THE LEG PIECE, THE ACCESSORY CAME LOOSE FROM THE TABLE AND FELL TO THE FLOOR. AS A RESULT, THE PATIENT¿S POSITION SHIFTED SLIGHTLY AS THE PATIENT SLID AND FELL ON TOP OF THE CUSHIONS OF THE FALLEN DEVICE. IT WAS CONFIRMED THAT THE MOVEMENT WAS RAPID AND THE PATIENT WAS NOT SECURED AT THE MOMENT OF THE FALL. THE OPERATION WAS DELAYED BY APPROXIMATELY 30 MINUTES DUE TO THE ISSUE. THE SURGERY WAS COMPLETED ON THE SAME ACCESSORY AS THE REPLACEMENT WAS NOT AVAILABLE. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL FOR SERIOUS INJURY IF THE SITUATION, NAMELY THE DETACHMENT OF THE ACCESSORY LEADING TO THE PATIENT¿S FALL, WAS TO REOCCUR. A REVIEW OF THE RECEIVED CUSTOMER PRODUCT COMPLAINTS REVEALED THAT THERE WERE NO SERIOUS INJURIES TO A USER NOR TO A PATIENT OR OPERATOR WHEN THIS PARTICULAR ISSUE OCCURRED. WITH THE INVESTIGATION PERFORMED IT WAS CONCLUDED THAT UPON THE EVENT OCCURRENCE, THE DEVICE WAS BEING USED FOR THE PATIENT¿S TREATMENT, AND THUS WAS ALSO DIRECTLY INVOLVED WITH THE REPORTED INCIDENT. AS THE MALFUNCTION OCCURRED, IT WAS CONSIDERED THAT THE GETINGE DEVICE FAILED TO MEET ITS SPECIFICATIONS. THE AFFECTED DEVICE WAS EVALUATED BY A GETINGE TECHNICIAN. THE 14400409 ROLL PIN ISO8752- 3X 16-A2, 50107014 BOLT, 40047934 SNAP-FT, LEFT AND 40047944 SNAP-FT, RIGHT WERE REPLACED, AND THE DEVICE WAS RELEASED FOR USAGE. ACCORDING TO THE INFORMATION PROVIDED BY THE CUSTOMER, THE LEG PIECE CAME OFF BECAUSE IT KEPT SNAGGING ON THE HOIST THAT MUST HAVE HAPPENED TO BE JUST BELOW IT. THE SUBJECT MATTER EXPERT (SME) AT THE MANUFACTURING SITE WAS CONTACTED TO ASSESS THE MOST PROBABLE ROOT CAUSE OF THE ISSUE. ACCORDING TO THE SME¿S EVALUATION, EVEN IF ONLY ONE BLACK BUTTON HAD BEEN PRESSED, THE ENTIRE ACCESSORY WOULDN'T CRASH, BUT WOULD STILL HANG DIAGONALLY ON THE TABLE BY THE OTHER ORANGE SAFETY LATCH. BASED ON THE SME¿S ASSESSMENT, BOTH BLACK BUTTONS MUST HAVE BEEN PRESSED BY SOMEONE WHILE THE 100704D0 - DEVICE FOR SPINAL SURGERY WAS IN THE Z POSITION OR WAS JUST BEING MOVED. IT IS ALSO POSSIBLE THAT THE CLOTHS GOT CAUGHT IN THE INTERFACE AND THE TWO SAFETY LATCHES WEREN'T ENGAGED. THE INSTRUCTION FOR USE FOR 100704D0 DEVICE FOR SPINAL SURGERY STATES THAT DURING ADJUSTING AND MOVING THE OR TABLE, THE TRANSPORTER, THE TABLE TOP OR THE ACCESSORIES, AS WELL AS WHEN CARRYING OUT A TABLE TOP TRANSFER, COLLISIONS MAY OCCUR BETWEEN THE PATIENT AND INDIVIDUAL PRODUCTS OR PARTS THAT ARE POINTING DOWNWARDS. DURING ADJUSTMENTS, OBSERVE THE OR TABLE, THE TRANSPORTER, THE TABLE TOP AND ACCESSORIES CONSTANTLY AND AVOID COLLISIONS (IFU 1007.04 REV. 20 PAGE 17). THE ACCESSORY/COLLISION RECOGNITION OF THE OR TABLE ONLY RECOGNIZES THE Z-POSITION OF THE KNEELING FRAME. ADDITIONAL ACCESSORIES MOUNTED TO THE KNEELING FRAME WILL NOT BE RECOGNIZED BY THE COLLISION RECOGNITION FEATURE. DURING ADJUSTMENT, OBSERVE THE MOVEMENTS AND ENSURE THAT NO COLLISIONS OCCUR (IFU 1007.04 REV. 20 PAGE 21). THE USER IS ALSO ADVISED TO ENSURE THAT PRODUCTS / ACCESSORIES ARE MOUNTED CORRECTLY, THE SECURING ELEMENTS (HANDLE SCREWS, CATCHES, LEVERS, ETC.) ARE CLOSED AND FIRMLY TIGHTENED, AND MOVING PARTS ARE CORRECTLY SECURED (IFU 1007.04 REV. 20 PAGE 17). IF LOCKING ELEMENTS (ECCENTRIC LEVERS, HANDLE SCREWS, LOCKS ETC.) ARE OPEN, THE PRODUCT/ACCESSORY CAN BE MOVED. BEFORE OPENING THE LOCKING ELEMENTS, HOLD THE INDIVIDUAL ITEMS FIRMLY. AFTER EVERY ADJUSTMENT PROCEDURE, ENSURE THAT ALL LOCKING ELEMENTS ARE CLOSED (IFU 1007.04 REV. 20 PAGE 18). IN SUMMARY, AS A RESULT OF THE PERFORMED ROOT CAUSE EVALUATION, IT CAN BE CONCLUDED THAT THE ROOT CAUSE OF THE REPORTED ISSUE, NAMELY THE DETACHMENT OF THE ACCESSORY LEADING TO THE PATIENT¿S FALL, IS MOST LIKELY RELATED TO USER ERROR. WE CURRENTLY DO NOT HAVE ANY INFORMATION THAT WOULD WARRANT FURTHER ACTION REGARDING DEVICE MANUFACTURING OR DEVICES ON THE MARKET, HOWEVER AS PER OUR COMPLAINT HANDLING PROCESSES WILL CONTINUE TO MONITOR THE CUSTOMER EXPERIENCES WITH THE DEVICE FOR ANY FUTURE INFORMATION. THE CORRECTION OF B5 DESCRIBE EVENT OR PROBLEM, H6 MEDICAL DEVICE ¿ PROBLEM CODE FIELDS DEEMS REQUIRED. THIS IS BASED ON THE INTERNAL EVALUATION. PREVIOUS B5 DESCRIBE EVENT OR PROBLEM: GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR TABLE TOPS - 100704D0 - DEVICE FOR SPINAL SURGERY USED WITH 118010A0 - BASIS TABLE TOP,INDIVIDUAL CONFIGURATION. AS IT WAS STATED, THE INCIDENT INVOLVING AN ANESTHETIZED PATIENT OCCURRED DURING POSITIONING BEFORE SPINAL HERNIA SURGERY. THE PATIENT WAS PLACED ON THE ABDOMEN ON THE TABLE. DURING FOLDING DOWN OF THE LEG PIECE, THE ACCESSORY CAME LOOSE FROM THE TABLE AND FELL TO THE FLOOR. AS A RESULT, THE PATIENT¿S POSITION SHIFTED SLIGHTLY AS THE PATIENT SLID AND FELL ON TOP OF THE CUSHIONS OF THE FALLEN DEVICE. IT WAS CONFIRMED THAT THE MOVEMENT WAS RAPID AND THE PATIENT WAS NOT SECURED AT THE MOMENT OF THE FALL. THE OPERATION WAS DELAYED BY APPROXIMATELY 30 MINUTES DUE TO THE ISSUE. THE SURGERY WAS COMPLETED ON THE SAME ACCESSORY AS THE REPLACEMENT WAS NOT AVAILABLE. ACCORDING TO THE INFORMATION PROVIDED FOLLOWING SERVICE VISIT ON SITE, 14400409 ROLL PIN ISO8752- 3X 16-A2, 50107014 BOLT, 40047934 SNAP-FT, LEFT AND 40047944 SNAP-FT, RIGHT WERE REPLACED. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL FOR SERIOUS INJURY IF THE SITUATION, NAMELY THE DETACHMENT OF THE ACCESSORY LEADING TO PATIENT¿S FALL, WAS TO REOCCUR. CORRECTED B5 DESCRIBE EVENT OR PROBLEM: GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR TABLE TOPS - 100704D0 - DEVICE FOR SPINAL SURGERY USED WITH 118010A0 - BASIS TABLE TOP,INDIVIDUAL CONFIGURATION. AS IT WAS STATED, THE INCIDENT INVOLVING AN ANESTHETIZED PATIENT OCCURRED DURING POSITIONING BEFORE SPINAL HERNIA SURGERY. THE PATIENT WAS PLACED ON THE ABDOMEN ON THE TABLE. DURING FOLDING DOWN OF THE LEG PIECE, THE ACCESSORY CAME LOOSE FROM THE TABLE AND FELL TO THE FLOOR. AS A RESULT, THE PATIENT¿S POSITION SHIFTED SLIGHTLY AS THE PATIENT SLID AND FELL ON TOP OF THE CUSHIONS OF THE FALLEN DEVICE. IT WAS CONFIRMED THAT THE MOVEMENT WAS RAPID AND THE PATIENT WAS NOT SECURED AT THE MOMENT OF THE FALL. THE OPERATION WAS DELAYED BY APPROXIMATELY 30 MINUTES DUE TO THE ISSUE. THE SURGERY WAS COMPLETED ON THE SAME ACCESSORY AS THE REPLACEMENT WAS NOT AVAILABLE. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL FOR SERIOUS INJURY IF THE SITUATION, NAMELY THE DETACHMENT OF THE ACCESSORY LEADING TO THE PATIENT¿S FALL, WAS TO REOCCUR. PREVIOUS H6 MEDICAL DEVICE ¿ PROBLEM CODE: MECHANICAL PROBLEM/DETACHMENT OF DEVICE OR DEVICE COMPONENT//2907. MECHANICAL PROBLEM/STRUCTURAL PROBLEM/DIFFICULT TO OPEN OR CLOSE/2921. CORRECTED H6 MEDICAL DEVICE ¿ PROBLEM CODE: MECHANICAL PROBLEM/DETACHMENT OF DEVICE OR DEVICE COMPONENT//2907. USE OF DEVICE PROBLEM///1670.

Description of Event or Problem

GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR TABLE TOPS - 100704D0 - DEVICE FOR SPINAL SURGERY USED WITH 118010A0 - BASIS TABLE TOP,INDIVIDUAL CONFIGURATION. AS IT WAS STATED, THE INCIDENT INVOLVING AN ANESTHETIZED PATIENT OCCURRED DURING POSITIONING BEFORE SPINAL HERNIA SURGERY. THE PATIENT WAS PLACED ON THE ABDOMEN ON THE TABLE. DURING FOLDING DOWN OF THE LEG PIECE, THE ACCESSORY CAME LOOSE FROM THE TABLE AND FELL TO THE FLOOR. AS A RESULT, THE PATIENT¿S POSITION SHIFTED SLIGHTLY AS THE PATIENT SLID AND FELL ON TOP OF THE CUSHIONS OF THE FALLEN DEVICE. IT WAS CONFIRMED THAT THE MOVEMENT WAS RAPID AND THE PATIENT WAS NOT SECURED AT THE MOMENT OF THE FALL. THE OPERATION WAS DELAYED BY APPROXIMATELY 30 MINUTES DUE TO THE ISSUE. THE SURGERY WAS COMPLETED ON THE SAME ACCESSORY AS THE REPLACEMENT WAS NOT AVAILABLE. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL FOR SERIOUS INJURY IF THE SITUATION, NAMELY THE DETACHMENT OF THE ACCESSORY LEADING TO THE PATIENT¿S FALL, WAS TO REOCCUR.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION. E1 INITIAL REPORTER: (B)(6).

Description of Event or Problem

GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR TABLE TOPS - 100704D0 - DEVICE FOR SPINAL SURGERY USED WITH 118010A0 - BASIS TABLE TOP,INDIVIDUAL CONFIGURATION. AS IT WAS STATED, THE INCIDENT INVOLVING AN ANESTHETIZED PATIENT OCCURRED DURING POSITIONING BEFORE SPINAL HERNIA SURGERY. THE PATIENT WAS PLACED ON THE ABDOMEN ON THE TABLE. DURING FOLDING DOWN OF THE LEG PIECE, THE ACCESSORY CAME LOOSE FROM THE TABLE AND FELL TO THE FLOOR. AS A RESULT, THE PATIENT¿S POSITION SHIFTED SLIGHTLY AS THE PATIENT SLID AND FELL ON TOP OF THE CUSHIONS OF THE FALLEN DEVICE. IT WAS CONFIRMED THAT THE MOVEMENT WAS RAPID AND THE PATIENT WAS NOT SECURED AT THE MOMENT OF THE FALL. THE OPERATION WAS DELAYED BY APPROXIMATELY 30 MINUTES DUE TO THE ISSUE. THE SURGERY WAS COMPLETED ON THE SAME ACCESSORY AS THE REPLACEMENT WAS NOT AVAILABLE. ACCORDING TO THE INFORMATION PROVIDED FOLLOWING SERVICE VISIT ON SITE, 14400409 ROLL PIN ISO8752- 3X 16-A2, 50107014 BOLT, 40047934 SNAP-FT, LEFT AND 40047944 SNAP-FT, RIGHT WERE REPLACED. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL FOR SERIOUS INJURY IF THE SITUATION, NAMELY THE DETACHMENT OF THE ACCESSORY LEADING TO PATIENT¿S FALL, WAS TO REOCCUR.