inforMED
MalfunctionNFB

DRIVEMEDICAL OXYMIZER DISPOSABLE OXYGEN CONSERVER

Received Oct 26, 2020 · Event occurred Sep 2, 2020

Report 10733037 · MDR key 10733037

Device

Generic name

Conserver, Oxygen

Catalog number

O-224

Product problems

  • Scratched Material

Patient

21900 DA

  • Pressure Sore/Ulcer
  • Pressure Sore/Ulcer

Narrative

Description of Event or Problem

SUMMARY OF EVENT: 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. OUR CONCERNS REGARDING OXYMIZER: CAN CAUSE INJURY UNDER THE NOSE RELATED TO SEAM. THERE IS A SEAM/WELD WHERE THE PLASTIC COMES TOGETHER. THIS IS A FIRM, SLIGHTLY SHARP RAISED EDGE THAT CAN CAUSE ISSUE IF IT PRESSES INTO THE NARES/NASAL SEPTUM. TUBING ON OXYMIZER IS NOT SOFT AND REQUIRES ADDITIONAL TUBING ADDED FOR PRESSURE REDUCTION, THIS TUBING IS NOT ALWAYS RELIABLE AS AN INTENTION FOR PRESSURE INJURY PREVENTION SINCE IT FALLS DOWN. TUBING IS REQUIRED TO BE SECURE WITH THE CINCH AT THE CHIN IN ORDER TO HOLD THE RESERVOIR AND PRONGS IN PLACE IN THE NARES. THIS CAUSES THE PRESSURE TO HANG ON THE TOP AND THE BACK OF THE EARS, AS WELL AS RISK TO SECURE TOO TIGHT TO CREATE PRESSURE AT THE NASAL SEPTUM AND CHEEKS. STEPS TAKEN BY FACILITY: CREATED OXYMIZER BEST PRACTICES TO ENSURE OXYMIZER IS PRESSURE INJURY SAFE: FOR PATIENTS WITH OXYMIZERS, MAKE SURE THE RESPIRATORY DEVICE IS PRESSURE INJURY SAFE. WRAP FOAM TAPE OR MEPILEX AROUND THE MIDDLE SEAM AND ADD GREY FOAM PADS TO THE EARS ¿ THE TUBING IS NOT THE SOFT TUBING. IT IS OKAY TO COVER THE MIDDLE VENTS AS THERE WILL BE OPEN VENTS ON BOTH SIDES. WE HAVE ALSO IMPLEMENTED THE ADDED STEP OF PLACING A STICKER WITH THESE INSTRUCTIONS ON A MAJORITY (BUT NOT ALL) OF THE OXYMIZER PACKAGES AS A REMINDER TO PERFORM THESE ACTIONS.