RCS, IDS, 3RD ED, NON-ROHS RETCAM SHUTTLE

Additional Manufacturer Narrative

14 AUG 2020 (REF NATUS COMPLAINT NO.# (B)(4)). INVESTIGATION AND FINDINGS: 20-JULY 2020: TECHNICAL SERVICE PROVIDED INFORMATION TO HELP IMPROVE THE SYSTEM PERFORMANCE. 27-JULY-2020: THE CUSTOMER ADVISED THE LAPTOP HAS BEEN RE-IMAGED. THE CUSTOMER CONFIRMED THAT THERE WAS PATIENT INVOLVEMENT AT THE TIME OF THE INCIDENT. THE "LOSS OF EXAM RESULTED IN REIMAGING THE INFANTS - CAUSING INCREASED APNEA/BRADYCARDIA EPISODES FOLLOWING THE IMAGING." THE CUSTOMER CONFIRMED THERE WAS NO DEATH, SERIOUS INJURY, DELAY IN TREATMENT, ENVIRONMENTAL OR SAFETY CONCERNS. 31-JULY-2020: THE CUSTOMER REIMAGED THE SYSTEM AND IT'S WORKING NOW. 03-AUGUST-2020: THE SYSTEM IS STILL VERY SLOW ALTHOUGH IT'S BETTER THEN BEFORE. THE CUSTOMER IS WONDERING IF THEY SHOULD GET A NEW COMPUTER AS THEIR IS "NEARLY 10 YEARS." . TECH ADVISED THAT THE RETCAM SYSTEM IS NOW IN LIMITED SUPPORT AND PROVIDED THE CUSTOMER WITH A LIMITED SUPPORT LETTER. THE SYSTEM ENTERED LIMITED SUPPORT ON DECEMBER 31, 2019. 12-AUGUST-2020: TECHNICAL SUPPORT TO CONFIRM IF THE ALLEGEDLY DEFECTIVE PART CAN BE SEND BACK OR HAVE SOMEONE GO ONSITE AND EVALUATE THE SYSTEM. CAPA AND COMPLAINT TRENDING REVIEW: 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) PROCEDURE, COMPLAINT HISTORIES ARE REVIEW ROUTINELY PER QUALITY SYSTEM REQUIREMENTS AND ANY COMPLAINT TRENDS ARE ASSESSED AND DOCUMENTED AS PART OF THESE REVIEWS. NO COMPLAINT TRENDS HAVE BEEN IDENTIFIED. RISK MANAGEMENT FILE REVIEW: PER INFORMATION FOUND IN RISK ASSESSMENT_18-000022 REV Q, RISK ASSESSMENT RETCAM, REF. LINE 9.1.5, HAZARD CATEGORY - DELAYED PROCEDURE, SAFETY RISK - ACCEPTABLE.

Description of Event or Problem

THE LAPTOP IS RUNNING SLOW. THE USER REPORTS THAT THE LAPTOP FREQUENTLY FREEZES, SOMETIMES IT WILL UNFREEZE SPONTANEOUSLY AND OTHER TIMES IT HAS TO BE RESTARTED, CAUSING THE EXAM TO BE LOST. THE CUSTOMER CONFIRMED THERE WAS NO DEATH, SERIOUS INJURY, DELAY IN TREATMENT, ENVIRONMENTAL OR SAFETY CONCERNS.

Description of Event or Problem

THE LAPTOP IS RUNNING SLOW. THE USER REPORTS THAT THE LAPTOP FREQUENTLY FREEZES, SOMETIMES IT WILL UNFREEZE SPONTANEOUSLY AND OTHER TIMES IT HAS TO BE RESTARTED, CAUSING THE EXAM TO BE LOST. THE CUSTOMER CONFIRMED THERE WAS NO DEATH, SERIOUS INJURY, DELAY IN TREATMENT, ENVIRONMENTAL OR SAFETY CONCERNS.

Additional Manufacturer Narrative

(B)(6) 2020 (REF NATUS COMPLAINT NO.# (B)(4). TECHNICAL SUPPORT WILL NOT BE ABLE TO EVALUATE THE DEVICE ONSITE. THE DEVICE HAS BEEN REQUESTED BACK FROM THE CUSTOMER, FOR EVALUATION.

Description of Event or Problem

THE LAPTOP IS RUNNING SLOW. THE USER REPORTS THAT THE LAPTOP FREQUENTLY FREEZES, SOMETIMES IT WILL UNFREEZE SPONTANEOUSLY AND OTHER TIMES IT HAS TO BE RESTARTED, CAUSING THE EXAM TO BE LOST. THE CUSTOMER CONFIRMED THERE WAS NO DEATH, SERIOUS INJURY, DELAY IN TREATMENT, ENVIRONMENTAL OR SAFETY CONCERNS.

Additional Manufacturer Narrative

(B)(6) 2020 (REF NATUS COMPLAINT NO.# (B)(4)). INVESTIGATION AND FINDINGS: THE RETCAM SYSTEM HAS BEEN RECEIVED FOR EVALUATION AND THE FOLLOW WAS NOTED: (B)(6) 2020 THE TECHNICIAN FOUND THAT THE HANDPIECE SHELL WAS BROKEN AND THAT THE EO BOX HAD TWO BRACKET SCREWS MISSING AND DUST IN THE VENT. (B)(6) 2020 THE TECHNICIAN FOUND THAT THE SYSTEM IS MISSING THE HANDPIECE HOLSTER AND PORTRAIT LENS. IT'S UNCLEAR IF THE HANDPIECE HOLSTER AND PORTRAIT LENS WERE SENT WITH THE LOANER RETCAM PORTABLE. THE TECHNICIAN LOGGED INTO THE LAPTOP AND FOUND ONE DOMAIN. THE TECHNICIAN SELECTED, SHOW ALL AND FOUND 11 PATIENTS AND 288 MEDIA. OF THE PATIENTS, ONE WAS A TEST PATIENTS AND 4 PATIENTS INCLUDING THE TEST PATIENT HAD NO EXAMS. THERE WERE NO VIDEO FILES FOUND ON THE SYSTEM. THE TECHNICIAN TOOK 3 NEW EXAMS WITH 2 MINUTE VIDEO AND SELECTED 10 STILLS FROM THE VIDEOS. THE TECHNICIAN ALSO TOOK 3 NEW EXAMS WITH JUST STILLS. THE TECHNICIAN COULD NOT VERIFY THE PROBLEM USING THE FOOTSWITCH, SOFTWARE AND 'S' KEY ON THE KEYBOARD. (B)(6) 2020: THE TECHNICIAN THAT EVALUATED THE RETCAM ,REACHED OUT TO THE CUSTOMER AND ADVISED THEY HAVE NOT BEEN ABLE TO VERIFY THE REPORTED PROBLEM. HOWEVER, THE TECHNICIAN DID FIND THAT THE HANDPIECE SHELL IS CRACKED AND THERE IS DUST BUILDUP ON THE FAN VENT OF THE EO BOX. FOR THE EO BOX, THE TECHNICIAN WILL VACUUM THE VENT AND RECOMMENDS THAT BIOMED PERFORM A PERIODIC MAINTENANCE TO MAKE SURE THE VENT IS DUST FREE TO PREVENT AN OVERTEMP CONDITION. AWAITING REVIEW AND APPROVAL OF FINAL DETAILS BEFORE SUBMITTING FINAL REPORT.

Description of Event or Problem

THE LAPTOP IS RUNNING SLOW. THE USER REPORTS THAT THE LAPTOP FREQUENTLY FREEZES, SOMETIMES IT WILL UNFREEZE SPONTANEOUSLY AND OTHER TIMES IT HAS TO BE RESTARTED, CAUSING THE EXAM TO BE LOST. THE CUSTOMER CONFIRMED THERE WAS NO DEATH, SERIOUS INJURY, DELAY IN TREATMENT, ENVIRONMENTAL OR SAFETY CONCERNS.

Additional Manufacturer Narrative

(B)(6) 2020 (REF NATUS COMPLAINT NO.# (B)(4).) INVESTIGATIONS AND FINDINGS: THE RETCAM SYSTEM HAS BEEN RECEIVED FOR EVALUATION AND THE FOLLOW WAS NOTED: (B)(6) 2020 THE TECHNICIAN FOUND THAT THE HANDPIECE SHELL WAS BROKEN AND THAT THE EO BOX HAD TWO BRACKET SCREWS MISSING AND DUST IN THE VENT. (B)(6) 2020 THE TECHNICIAN FOUND THAT THE SYSTEM IS MISSING THE HANDPIECE HOLSTER AND PORTRAIT LENS. IT'S UNCLEAR IF THE HANDPIECE HOLSTER AND PORTRAIT LENS WERE SENT WITH THE LOANER RETCAM PORTABLE. THE TECHNICIAN LOGGED INTO THE LAPTOP AND FOUND ONE DOMAIN. THE TECHNICIAN SELECTED, SHOW ALL AND FOUND 11 PATIENTS AND 288 MEDIA. OF THE PATIENTS, ONE WAS A TEST PATIENTS AND 4 PATIENTS INCLUDING THE TEST PATIENT HAD NO EXAMS. THERE WERE NO VIDEO FILES FOUND ON THE SYSTEM. THE TECHNICIAN TOOK 3 NEW EXAMS WITH 2 MINUTE VIDEO AND SELECTED 10 STILLS FROM THE VIDEOS. THE TECHNICIAN ALSO TOOK 3 NEW EXAMS WITH JUST STILLS. THE TECHNICIAN COULD NOT VERIFY THE PROBLEM USING THE FOOTSWITCH, SOFTWARE AND 'S' KEY ON THE KEYBOARD. (B)(6) 2020: THE TECHNICIAN THAT EVALUATED THE RETCAM ,REACHED OUT TO THE CUSTOMER AND ADVISED THEY HAVE NOT BEEN ABLE TO VERIFY THE REPORTED PROBLEM. HOWEVER, THE TECHNICIAN DID FIND THAT THE HANDPIECE SHELL IS CRACKED AND THERE IS DUST BUILDUP ON THE FAN VENT OF THE EO BOX.. FOR THE EO BOX, THE TECHNICIAN WILL VACUUM THE VENT AND RECOMMENDS THAT BIOMED PERFORM A PERIODIC MAINTENANCE TO MAKE SURE THE VENT IS DUST FREE TO PREVENT AN OVERTEMP CONDITION. (B)(6) 2020: THE TECHNICIAN VACUUMED THE EO BOX FAN VENT. THE EO BOX, FOOTSWITCH, AND LAPTOP ALL PASSED TESTING PER PROCEDURE. THE TECHNICIAN NOTED THAT SINCE THE MODULES WERE SENT IN WITHOUT THE RETCAM SHUTTLE CHASSIS, THE ELECTRICAL SAFETY TEST NEEDED TO BE PERFORMED ON THE HANDPIECE AND EO BOX SEPARATELY. THE MODULES PASSED THE ELECTRICAL SAFETY TESTS. (B)(6) 2020: ENGINEERING ALSO LOOKED AT THE SYSTEM. ENGINEERING "DID NOT SEE ANY PERFORMANCE ISSUES WITH ITS CURRENT STATUS." ENGINEERING NOTED THAT AS THE TECHNICIAN MENTIONED IT'S POSSIBLE SINCE THE DATA WAS WIPED AND THE EO BOX WAS VACUUMED THAT THESE FACTORS MAY HAVE CLEARED THE REPORTED PROBLEM. ENGINEERING NOTICED NO DELAYS IN LIVE IMAGING, THEY SAVED SEVERAL VIDEO AND STILLS, IT ALL PLAYED BACK WITH NO VISIBLE DELAY. TECHNICAL SUPPORT AND ENGINEERING BOTH TESTED THE SYSTEM (SEPARATELY) AND COULD NOT VERIFY THE REPORTED PROBLEM. THIS COMPLAINT COULD NOT BE VERIFIED, MONITOR FOR FUTURE OCCURRENCE. CAPA AND COMPLAINT TRENDING REVIEW: 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 REVIEW ROUTINELY PER QUALITY SYSTEM REQUIREMENTS AND ANY COMPLAINT TRENDS ARE ASSESSED AND DOCUMENTED AS PART OF THESE REVIEWS. NO COMPLAINT TRENDS HAVE BEEN IDENTIFIED." RISK MANAGEMENT FILE REVIEW: PER INFORMATION FOUND IN RISK ASSESSMENT_18-000022 REV Q, RISK ASSESSMENT RETCAM, REF. LINE 9.1.5, HAZARD CATEGORY - DELAYED PROCEDURE, SAFETY RISK - ACCEPTABLE. DHR REVIEW: A DHR REVIEW IS NOT APPLICABLE BECAUSE, PRIOR TO THE REPORTED ISSUE THE DEVICE WAS IN SERVICE FOR 2 OR MORE YEARS AND A MANUFACTURING DEFECT IS VERY UNLIKELY.