Description of Event or Problem · 1
INOVO, INC. IS THE MANUFACTURER OF THE DEVICE WHICH IS AN OXYMIZER, A DISPOSABLE OXYGEN CONSERVER. THE DEVICE WAS NOT RETURNED FOR EVALUATION. THIS REPORT IS IN RESPONSE TO THE FACILITY'S REPORT MW (B)(4). THE EVENT AS DESCRIBED BY THE FACILITY: PATIENT WAS PLACED ON THE OXYMIZER IN THE INTENSIVE CARE UNIT. THE PATIENT ALSO WORE HIS PERSONAL GLASSES CONTINUOUSLY WITH THE OXYMIZER TUBING AROUND THE EARS. THERE WERE NO PREVENTION MEASURES PUT IN PLACE FOR THE OXYMIZER TUBING UNTIL THE PRESSURE INJURIES WERE FOUND, AND ONCE IN PLACE, THE GREY FOAM ADDED TO THE TUBING AT THE TOP OF THE EARS DIDN'T ALWAYS STAY IN PLACE. THE PATIENT DEVELOPED A HOSPITAL-ACQUIRED UNSTAGEABLE PRESSURE INJURY ON THE RIGHT PROXIMAL EAR, STAGE 2 INJURY TO THE NASAL SEPTUM FROM THE SHARP PLASTIC SEAM OF THE NASAL OXYGEN RESERVOIR, AND STAGE 2 TO THE LEFT POSTERIOR EAR FROM THE HARD STIFF OXYGEN TUBING. PATIENT REQUIRED HIGHER LEVELS OF OXYGEN AND WAS UNABLE TO WEAN TO SOFTER TUBING NASAL CANNULA TO MINIMIZE PRESSURE FROM OXYGEN DEVICE. TESTING WAS CONDUCTED ON TWO DIFFERENT LOTS OF THE DEVICE. NO UNACCEPTABLE RISK WAS IDENTIFIED. NO COMPLAINTS FOR THIS ISSUE WERE NOTED IN THE LAST TWO YEARS. WITH A SALES VOLUME OF NINETY EIGHT THOUSAND UNITS WORLDWIDE. PRODUCT WAS USED OUTSIDE INTENDED USE STATEMENT. THE COMPLIANT STATED THAT THE DEVICE WAS BEING USED FOR A NON-AMBULATORY PATIENT IN THE ICU. THE INTENDED USE OF THE DEVICE, AS SHOWN IN APPENDIX B) IS: THE DEVICE IS INTENDED TO BE USED AS PART OF A PORTABLE OR STATIONARY OXYGEN SYSTEM FOR PATIENTS THAT REQUIRE SUPPLEMENTAL OXYGEN IN THEIR HOME AND FOR AMBULATORY USE. RECOMMENDATIONS HAVE BEEN DETERMINED AND ADDITIONAL DATA WILL BE COLLECTED FROM THE CONTRACT MANUFACTURER.