Pronova-O2 1Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00860006962203), received between Dec 9, 2025 and Jun 15, 2026 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Electrical Overstress” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 15, 2026Electrical Overstress; Mechanical Jam

  TURN MEDICAL IS SUBMITTING THIS REPORT OUT OF AN ABUNDANCE OF CAUTION. ON (B)(6) 2026, DURING USE OF THE PRONOVA O2 THERAPY SYSTEM, AN ERROR CODE INDICATING THAT THE PATIENT FRAME ROTATION HAD STALLED WAS DISPLAYED. PER THE ON SCREEN INSTRUCTIONS, THE USER CONTACTED TURN MEDICAL. A TURN MEDICAL EMPLOYEE VISITED THE FACILITY THE SAME DAY TO EVALUATE THE ISSUE. A COMPLETE SYSTEM SHUTDOWN WAS PERFORMED; HOWEVER, UPON RESTART, AN ADDITIONAL ERROR CODE WAS GENERATED. FACILITY STAFF WERE ADVISED TO EXCHANGE THE BED, AND A REPLACEMENT SYSTEM WAS PROVIDED ON (B)(6) 2026. THE PATIENT WAS TRANSFERRED TO THE NEW BED, AND THERAPY WAS RESUMED WITHOUT COMPLICATION. THE PATIENT TOLERATED THE TRANSFER WITHOUT DECOMPENSATION OR CLINICAL CONCERN, AND NO STAFF SAFETY ISSUES WERE REPORTED. FOLLOWING THE TRANSFER, ADDITIONAL IN-SERVICE TRAINING WAS PROVIDED TO DAY SHIFT AND NIGHT SHIFT STAFF OR (B)(6) 2026, WITH FURTHER TRAINING SCHEDULED FOR (B)(6) 2026. DURING EVALUATION OF THIS INCIDENT, TURN MEDICAL DID NOT IDENTIFY ANY DEATH, INJURY, OR DELAY IN THERAPY. THIS REPORT IS BEING SUBMITTED FOR THE IDENTIFIED MALFUNCTION IN THE EVENT THAT IT WERE TO RECUR. THIS INCIDENT WILL BE TRACKED FOR ANY INCREASE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25504493 ↗
• InjuryDec 9, 2025Adverse Event Without Identified Device or Use Problem; Unintended Movement; Adverse Event Without Identified Device or Use Problem; Unintended Movement

  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.

  Patient problems: Discomfort; Muscle/Tendon Damage

  MAUDE report 23758758 ↗