MAUDE Adverse Event Report: TURN MEDICAL, LLC. PRONOVA O2 THERAPY SYSTEM; BED, PATIENT ROTATION, POWERED

Catalog Number	PTS001
Medical Device Problem Codes	Electrical Overstress (2924); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/16/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
During use of the device, error code 101 - patient frame rotation stall detected was generated.Per the instructions for use (ifu), this error instructs the user to ensure that no obstacles are preventing rotation of the patient frame, verify that the patient is centered and secured between the side supports, and contact turn medical technical support if the issue persists.The facility employee followed the troubleshooting instructions and subsequently contacted turn medical when the issue was not resolved.A turn medical employee visited the facility and conducted a reboot and additional troubleshooting steps.An additional error code, 703 - system error (rmcu under voltage limit), was generated.Per the ifu, this error instructs the user to shut down the system, place the patient surface in a safe position using the manual cpr lever and emergency column down switches prior to shutdown, and contact turn medical technical support before restarting the system.A service request was subsequently initiated.On 21 may 2026, the turn medical service representative replaced the drive motor, belt, and rmcu board.Following completion of repairs, the device was verified to be operational.The cause of the stalled rotation could not be definitively determined.One contributing factor may be related to the patient's weight, which was reported to be approximately 380 lbs.; higher patient weights can affect weight distribution during rotation and contribute to belt slippage, potentially triggering a stall rotation error.
Event or Problem Description
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 in trends.

• Brand Name: PRONOVA O2 THERAPY SYSTEM
• Common Device Name: BED, PATIENT ROTATION, POWERED
• Manufacturer (Section D): TURN MEDICAL, LLC.; 1160 arion pkwy; ste 102; san antonio TX 78216
• Manufacturer (Section G): TURN MEDICAL, LLC; 1160 arion pkwy; ste 102; san antonio TX 78216
• Manufacturer Contact: denise valencia ; 1160 arion pkwy; ste 102; san antonio, TX 78216 ; 2105083832
• MDR Report Key: 25504493
• Report Number: 3016947689-2026-00002
• Device Sequence Number: 21463943
• Product Code: IKZ
• UDI-Device Identifier: 00860006962203
• UDI-Public: 00860006962203
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 06/15/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: PTS001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2026
• Initial Report FDA Received Date: 06/15/2026
• Date Device Manufactured: 01/18/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown
• Patient Weight: 172 KG