{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. 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ADDITIONAL INFORMATION: D4 - THE UDI NUMBER WAS POPULATED. THE MECHANICAL ENGINEER DOCUMENTED THE FOLLOWING INVESTIGATION DETAILS ON REPORT TPI-1743: NO PARTS WERE RETURNED FROM THE FIELD BUT A NUMBER OF PICTURES WERE SENT BY THE CUSTOMER OF THE CART AND THE FAILED COMPONENTS. THE PICTURES SHOW WEAR ON THE EDGE OF THE HOLE THE SCREW WAS IN AND PAINT TRANSFER FROM THE BLACK BRACKET TO THE SILVER CART WHERE THE BRACKET WAS RUBBING FOR SOME TIME WHILE THE SCREW WAS LOOSE. ROOT CAUSE/PROBABLE ROOT CAUSE: THE SCREW CAME LOOSE OVER TIME DUE TO USE OR VIBRATION DURING CART TRANSIT. RECOMMENDED ACTIONS: CREATE ENGINEER CHANGE REQUEST TO ADD SOME RETAINING METHOD FOR THE SCREW (THREAD LOCKING MATERIAL OR FASTENER) AND ENSURING THERE ARE WORK INSTRUCTIONS FOR THE INSTALLATION OF THE MAST ON THE CART COVERING PROPER INSTALLATION OF THE SCREWS. THE QA TECHNICIAN REVIEWED THE DEVICE HISTORY RECORD. NO ISSUES NOTED. A SEARCH FOR SERVICE DATA THAT MAY HAVE BEEN RELEVANT TO THIS ISSUE WAS CONDUCTED. NO FURTHER INFORMATION RELATED TO THIS ISSUE WAS FOUND." }, { "mdr_text_key": "326920395", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "TROLLEY CART VIDEO UPGRADE - CAMERA FELL OF POLE. NO DEATH OR SERIOUS INJURY OCCURRED." }, { "mdr_text_key": "260428582", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "INITIAL REPORT REF NATUS COMPLAINT# (B)(4). TROLLEY CART VIDEO UPGRADE - CAMERA FELL OF POLE. THE CUSTOMER THINKS A SCREW IS MISSING AND MAY BE WHAT CAUSED THE CAMERA TO FALL. NOBODY WAS AROUND NOR INJURED WHEN THE CAMERA FELL. THE CUSTOMER RETURNED RESPONSES TO THE AE QUESTIONNAIRE AND CONFIRMED THAT THE DEVICE WAS NOT BEING USED FOR PATIENT CARE AT THE TIME OF THE EVENT AND NO DEATH OR SERIOUS INJURY OCCURRED. 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. ACCEPTABLE RISK ASSOCIATED WITH THE COMPLAINT AS PER LINE (B)(4) IN (B)(4) XLTEK EEG PSG RISK ANALYSIS SPREADSHEET. 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 PROBABLY OF OCCURRENCE HAS NOT CHANGED. 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." }, { "mdr_text_key": "260428583", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "TROLLEY CART VIDEO UPGRADE - CAMERA FELL OF POLE. NO DEATH OR SERIOUS INJURY OCCURRED." }, { "mdr_text_key": "326029153", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "FOLLOW UP 001 REPORT REF SR# (B)(4). ADDITIONAL INFORMATION: H4 - MANUFACTURING DATE OF DEVICE ADDED. THE AFFECTED PRODUCT IS AWAITING RETURN FOR FURTHER INVESTIGATION. CORRECTION: B3 - EVENT DATE UPDATED FROM (B)(6) 2021." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "08/06/2021;10/29/2021" } ] }