BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRONOVA-O2

    MDR report key: 24270329 · Received February 5, 2026

    Report

    Report Number
    3016947689-2026-00001
    Event Type
    Malfunction
    Date Received
    February 5, 2026
    Date of Event
    January 12, 2026
    Report Date
    February 5, 2026
    Manufacturer
    TURN MEDICAL, LLC
    Product Code
    IKZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INSPECTION OF THE FAILED PRONOVAO2 (FIVE YEARS OLD) IDENTIFIED THAT THE HOUSING OF THE POWER CABLE RUNNING FROM THE MOTOR CONTROLLER TO THE MOTOR HAD MELTED. THE ASSET WAS RETURNED TO THE SAN ANTONIO OFFICES FOR EVALUATION. AN EFFORT TO RECREATE THE FAILURE WAS CONDUCTED ON BOTH THE RETURNED DEVICE AND ONE IN THE FACILITY. WHEN THE SAME WIRES WERE SHORTED, ON THE SECOND UNIT, THE STALL ERROR WAS THROWN, BUT THERE WAS NO SMOKE GENERATED. THE MOTOR AND BOARD WERE REPLACED IN THE FAILED UNIT.

    Description of Event or Problem · 0

    TURN MEDICAL IS SUBMITTING THIS REPORT REGARDING AN INCIDENT THAT OCCURRED DURING USE OF THE PRONOVA O2 THERAPY SYSTEM IN THE FIELD. ON (B)(6) 2026, DURING A STAFF SHIFT CHANGE, SMOKE WAS OBSERVED AT THE FOOT OF THE BED WHILE A PATIENT WAS IN THE PRONE POSITION (THIS INCIDENT OCCURRED ON THE SECOND DAY OF THERAPY). THE BED WAS IMMEDIATELY UNPLUGGED, AND THE PATIENT WAS REMOVED FROM THE DEVICE AND TRANSFERRED TO AN ICU BED. NO INJURIES WERE REPORTED, AND THE PATIENT'S THERAPY WAS COMPLETED WITHOUT FURTHER INCIDENT. AN ERROR MESSAGE WAS PRESENT ON THE USER INTERFACE, ALTHOUGH THE SPECIFIC ALERT WAS NOT DOCUMENTED. THE DEVICE WAS REMOVED FROM SERVICE AND RETURNED TO TURN MEDICAL FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330346 PRONOVA-O2 BED, PATIENT ROTATION, POWERED IKZ TURN MEDICAL, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention