PRONOVA-O2

Additional Manufacturer Narrative

DURING THE INVESTIGATION, THE SERIAL NUMBER OF THE DEVICE ASSOCIATED WITH THE ALLEGED INJURY COULD NOT BE IDENTIFIED. MULTIPLE ATTEMPTS TO OBTAIN THE SERIAL NUMBER FROM THE HOSPITAL WERE ATTEMPTED WITHOUT SUCCESS. ALTHOUGH THE SPECIFIC SERIAL NUMBER REMAINS UNKNOWN, THE DEVICE WAS DETERMINED TO HAVE BEEN MANUFACTURED IN EITHER 2021 OR 2022. TURN MEDICAL CURRENTLY UTILIZES A THIRD-PARTY AFFILIATE, NEW SOURCE MEDICAL (NSM), FOR DEVICE SERVICING. THE DEVICE IS REUSABLE, AND AFTER EACH USE IT IS RETURNED TO NSM FOR CLEANING, DISINFECTION, AND QUALITY CONTROL (QC). A REVIEW OF ALL QC REPORTS FROM (B)(6) 2025 SHOWED NO DEVICE MALFUNCTIONS, AND ALL UNITS PASSED QC FOR SUBSEQUENT USE. TURN MEDICAL CONFIRMED THAT THE IFU PROVIDES APPROPRIATE INSTRUCTION FOR OPENING AND CLOSING THE PRONE PANELS. THIS COMPLAINT WILL BE CLOSED UNLESS ADDITIONAL INFORMATION IS PROVIDED TO THE COMPANY.

Description of Event or Problem

TURN MEDICAL IS SUBMITTING THIS REPORT REGARDING AN ALLEGED INJURY ASSOCIATED WITH THE USE OF THE PRONOVA-O2 THERAPY SYSTEM. ON (B)(6) 2025, DURING A ROUTINE CALL WITH FACILITY MANAGEMENT, IT WAS DISCLOSED THAT THE INCIDENT HAD OCCURRED ON (B)(6) 2025. ACCORDING TO THE REPORTING NURSE MANAGER, THE EMPLOYEE WAS ASSISTING IN POSITIONING A PATIENT INTO SUPINATION WHEN THE HATCH AT THE UPPER END OF THE DEVICE UNEXPECTEDLY SPRANG BACK, STRIKING THE EMPLOYEE'S RIGHT WRIST AND RESULTING IN A SPRAIN. THE EMPLOYEE WAS SUBSEQUENTLY PLACED ON WORKERS' COMPENSATION AND REFERRED TO OCCUPATIONAL MEDICINE. AS OF (B)(6) 2025, THE NURSE MANAGER REPORTED THAT THE EMPLOYEE IS "OK" AND CURRENTLY WORKING UNDER LIGHT DUTY RESTRICTIONS. AN INVESTIGATION INTO THE INCIDENT DID NOT IDENTIFY ANY CONTRIBUTING FACTORS, NOR WAS ANY DEFICIENCY IN THE TURN MEDICAL DEVICE. TURN MEDICAL CONFIRMED THAT THE IFU PROVIDES APPROPRIATE INSTRUCTION FOR OPENING AND CLOSING THE PRONE PANELS.