OLYMPIC VAC-PAC SIZE 31

Description of Event or Problem

INCIDENT OF PATIENT SLIPPING ON TABLE WHILE IN THE VAC PAC IN TRENDELENBURG POSITION.NO INJURY OR HARM OCCURRED AS A RESULT OF THE MOVEMENT.

Additional Manufacturer Narrative

FOLLOW UP 002 (REF NATUS COMPLAINT #(B)(4) PER COMPLETED QUESTIONNAIRE FROM END USER: EVENT DATE: (B)(6) 2020. PROCEDURE: COLO-RECTAL SURGERY. EVENT: VAC-PAC SLIPPED DOWN, USAGE OF DEVICE: (B)(6) 2020. NO INJURY TO PATIENT, DELAY IN TREATMENT: YES. TECHNICAL SERVICE E-MAILED CUSTOMER ADDITIONAL QUESTIONS FOR END USER. ON 22 JAN 2021 END USER'S RESPONSE TO QUESTIONS: VAC-PAC DID NOT LOSE VACUUM. PATIENT RE-POSITIONED AS LEGS WERE STRAIGHT IN STIRRUPS AND CUSHIONS MOVED. SAFETY STRAPS NOT USED BECAUSE OF LITHOTOMY POSITION TO ACCESS ABDOMEN AND NOT RECOMMENDED TO STRAP CHEST. THE END USER REPORTED SAFETY STRAPS WERE NOT USED WITH THE VAC-PAC. THE CUSTOMER MAY NOT UNDERSTAND THE LIMITS OF THE INTENDED USE OF THE DEVICE. THE DEVICE IS A POSITIONING DEVICE AND IS NOT DESIGNED WITH FEATURES OR FUNCTION THAT ALLOW IT TO ADHERE OR SECURELY FASTEN ITSELF TO THE SURFACE IT IS PLACED ON. THE IFU PROVIDES A WARNING OR GUIDANCE REGARDING THIS ON PAGE# 5 "WARNINGS AND CAUTIONS, WHEN PLACING THE PATIENT IN THE TRENDELENBURG POSITION, DO NOT USE THE VAC-PAC AS THE SOLE MEANS OF SUPPORTING THE PATIENT. USE OTHER TABLE-ATTACHED DEVICES IN CONJUNCTION WITH THE VAC-PAC TO INCREASE SUPPORT OF THE PATIENT. INVESTIGATION ACTIONS: 1. PERFORMED A QUERY OF THE COMPLAINTS DATABASE TO CHECK FOR SIMILAR COMPLAINTS AND OR TREND. 2. COMMUNICATED WITH CONTRACT MANUFACTURER REGARDING THE DEVICE AND THEY CONFIRMED THERE HAVE BEEN NO RECENT PRODUCT CHANGES. 3. PART NUMBER 51631 HISTORY WAS REVIEWED FOR CHANGES TO THE PRODUCT. 4. REQUESTED THAT ENGINEERING REVIEW THE INVESTIGATION INFORMATION AND PROVIDE FEEDBACK. 5. VERIFIED BOM TO CONFIRM A COPY OF THE IFU INCLUDED WITH PRODUCT. 6. COMPLETED SCAR E-MAILED TO TECHNICAL SERVICE ON 11 FEB 2021 FOR TECHNICAL SERVICE TO E-MAIL TO THE DISTRIBUTOR. PRODUCT RETURN WAS DETERMINED TO BE UNNECESSARY BECAUSE THE PART NUMBER AND LOT NUMBER WERE PROVIDED BY THE CUSTOMER. THERE WAS NO INFORMATION INDICATING THE PRODUCT MALFUNCTIONED. A RISK REVIEW IS NOT REQUIRED AS THIS COMPLAINT DOES NOT DESCRIBE A NEW FAILURE MODE OR NEW HARM AND THE EXISTING HAZARD SEVERITY AND/OR PROBABILITY OF OCCURRENCE HAS NOT CHANGED. DOC-04662 REV. E VAC-PAC RISK ANALYSIS, I.D. 13.1 SEVERITY SCORE IS MODERATE, AND THE RISK RATING SCORE 6 IS LOW. THERE ARE NO CAPA'S RELATED TO THIS ISSUE AND THIS COMPLAINT DOES NOT IDENTIFY A DEFICIENCY IN THE PRODUCT DESIGN AND THEREFORE A CAPA IS NOT REQUIRED. PER QMS-004442 COMPLAINT HISTORIES ARE REVIEWED ROUTINELY PER QUALITY SYSTEM REQUIREMENTS AND ANY COMPLAINT TRENDS ARE ASSESSED AND DOCUMENTED AS PART OF THESE REVIEWS. NO COMPLAINT TRENDS HAVE BEEN IDENTIFIED. INVESTIGATION RESULT CODE: SEATTLE/FAILURE TO FOLLOW INSTRUCTIONS CLOSURE RATIONALE: NO ACTION NECESSARY, USER MISUNDERSTANDING.

Additional Manufacturer Narrative

FOLLOW UP 001 (REF NATUS COMPLAINT # (B)(4)) PER COMPLETED QUESTIONNAIRE FROM END USER: EVENT DATE: (B)(6) 2020. PROCEDURE: COLO-RECTAL SURGERY. EVENT: VAC-PAC SLIPPED DOWN, USAGE OF DEVICE: (B)(6) 2020. NO INJURY TO PATIENT, DELAY IN TREATMENT: YES. TECHNICAL SERVICE E-MAILED CUSTOMER ADDITIONAL QUESTIONS FOR END USER. ON (B)(6) 2021 END USER'S RESPONSE TO QUESTIONS: VAC-PAC DID NOT LOSE VACUUM. PATIENT RE-POSITIONED AS LEGS WERE STRAIGHT IN STIRRUPS AND CUSHIONS MOVED. SAFETY STRAPS NOT USED BECAUSE OF LITHOTOMY POSITION TO ACCESS ABDOMEN AND NOT RECOMMENDED TO STRAP CHEST. THE END USER REPORTED SAFETY STRAPS WERE NOT USED WITH THE VAC-PAC. THE CUSTOMER MAY NOT UNDERSTAND THE LIMITS OF THE INTENDED USE OF THE DEVICE. THE DEVICE IS A POSITIONING DEVICE AND IS NOT DESIGNED WITH FEATURES OR FUNCTION THAT ALLOW IT TO ADHERE OR SECURELY FASTEN ITSELF TO THE SURFACE IT IS PLACED ON. THE IFU PROVIDES A WARNING OR GUIDANCE REGARDING THIS ON PAGE# 5 "WARNINGS AND CAUTIONS, WHEN PLACING THE PATIENT IN THE TRENDELENBURG POSITION, DO NOT USE THE VAC-PAC AS THE SOLE MEANS OF SUPPORTING THE PATIENT. USE OTHER TABLE-ATTACHED DEVICES IN CONJUNCTION WITH THE VAC-PAC TO INCREASE SUPPORT OF THE PATIENT. INVESTIGATION ACTIONS: 1. PERFORMED A QUERY OF THE COMPLAINTS DATABASE TO CHECK FOR SIMILAR COMPLAINTS AND OR TREND. 2. COMMUNICATED WITH CONTRACT MANUFACTURER REGARDING THE DEVICE AND THEY CONFIRMED THERE HAVE BEEN NO RECENT PRODUCT. CHANGES. 3. PART NUMBER 51631 HISTORY WAS REVIEWED FOR CHANGES TO THE PRODUCT. 4. REQUESTED THAT ENGINEERING REVIEW THE INVESTIGATION INFORMATION AND PROVIDE FEEDBACK. 5. VERIFIED BOM TO CONFIRM A COPY OF THE IFU INCLUDED WITH PRODUCT. 6. COMPLETED SCAR E-MAILED TO TECHNICAL SERVICE ON (B)(6) 2021 FOR TECHNICAL SERVICE TO E-MAIL TO THE DISTRIBUTOR. PRODUCT RETURN WAS DETERMINED TO BE UNNECESSARY BECAUSE THE PART NUMBER AND LOT NUMBER WERE PROVIDED BY THE CUSTOMER. THERE WAS NO INFORMATION INDICATING THE PRODUCT MALFUNCTIONED. A RISK REVIEW IS NOT REQUIRED AS THIS COMPLAINT DOES NOT DESCRIBE A NEW FAILURE MODE OR NEW HARM AND THE EXISTING HAZARD SEVERITY AND/OR PROBABILITY OF OCCURRENCE HAS NOT CHANGED. DOC-04662 REV. E VAC-PAC RISK ANALYSIS, I.D. 13.1 SEVERITY SCORE IS MODERATE, AND THE RISK RATING SCORE 6 IS LOW. THERE ARE NO CAPA'S RELATED TO THIS ISSUE AND THIS COMPLAINT DOES NOT IDENTIFY A DEFICIENCY IN THE PRODUCT DESIGN AND THEREFORE A CAPA IS NOT REQUIRED. PER QMS-004442 COMPLAINT HISTORIES ARE REVIEWED ROUTINELY PER QUALITY SYSTEM REQUIREMENTS AND ANY COMPLAINT TRENDS ARE ASSESSED AND DOCUMENTED AS PART OF THESE REVIEWS. NO COMPLAINT TRENDS HAVE BEEN IDENTIFIED. FINAL REVIEW AND APPROVAL OF INVESTIGATION RESULTS TO BE COMPLETED.

Description of Event or Problem

INCIDENT OF PATIENT SLIPPING ON TABLE WHILE IN THE VAC PAC IN TRENDELENBURG POSITION. NO INJURY OR HARM OCCURRED AS A RESULT OF THE MOVEMENT.

Additional Manufacturer Narrative

21 JAN 2021 INITIAL REPORT (REF NATUS COMPLAINT (B)(4)). ON THE 14 JAN 2021 A DISTRIBUTOR SUBMITTED A SUPPLY CORRECTION ACTION REPORT FOR THE OLYMPIC VAC-PAC SURGICAL POSITIONER. THE SCAR WAS INITIATED BECAUSE ONE OF THEIR END USER ACCOUNTS REPORTED THAT ON TWO SEPARATE OCCASIONS PATIENTS MOVED ON THE OPERATING TABLE DURING PROCEDURES WHILE USING THE VAC-PAC DEVICE. ACCORDING TO THE INFORMATION RECEIVED NO INJURY OR HARM OCCURRED AS A RESULT OF THE MOVEMENT. THE END USER REQUESTED THAT NATUS INVESTIGATE THE POSSIBILITY OF A MATERIAL CHANGE WHICH THEY SUSPECT MAY HAVE CONTRIBUTED TO THE MOVEMENT OF THE DEVICE. THE PATIENT WAS PLACED IN THE NATUS VAC-PAC POSITIONING DEVICE WHICH WAS PLACED DIRECTLY ON THE OPERATING ROOM TABLE. THE PATIENT WAS ALSO IN IN BOOT STIRRUPS ORIENTED IN THE TRENDELENBURG AND LITHOTOMY POSITION. THE CUSTOMER HAS BEEN USING THIS DEVICE FOR OVER TEN YEARS. THEY ALLEGE THAT THE ISSUE HAS NOT OCCURRED UNTIL RECENTLY WHEN THEY STARTED USING A "NEW" VAC-PAC. THE END USER COMPARED AN OLDER VAC-PAC WITH A MORE RECENTLY PURCHASED DEVICE AND OBSERVED A NOTICEABLE DIFFERENCE IN THE OUTER MATERIAL. FURTHER INVESTIGATION TO BE CARRIED OUT. THERE ARE NO CAPA'S RELATED TO THIS ISSUE AND THIS COMPLAINT DOES NOT IDENTIFY A DEFICIENCY IN THE PRODUCT DESIGN AND THEREFORE A CAPA IS NOT REQUIRED. PER (B)(4) COMPLAINT HISTORIES ARE REVIEWED ROUTINELY PER QUALITY SYSTEM REQUIREMENTS AND ANY COMPLAINT TRENDS ARE ASSESSED AND DOCUMENTED AS PART OF THESE REVIEWS. NO COMPLAINT TRENDS HAVE BEEN IDENTIFIED.

Description of Event or Problem

INCIDENT OF PATIENT SLIPPING ON TABLE WHILE IN THE VAC PAC IN TRENDELENBURG POSITION. NO INJURY OR HARM OCCURRED AS A RESULT OF THE MOVEMENT.