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

Catalog Number	PTS001
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Unintended Movement (3026)
Health Effect - Clinical Codes	Discomfort (2330); Muscle/Tendon Damage (4532)
Date of Event	10/23/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
During the investigation, the serial number of the device associated with the alleged injury could not be identified.Multiple attempts to obtain the serial number from the hospital were attempted without success.Although the specific serial number remains unknown, the device was determined to have been manufactured in either 2021 or 2022.Turn medical currently utilizes a third-party affiliate, new source medical (nsm), for device servicing.The device is reusable, and after each use it is returned to nsm for cleaning, disinfection, and quality control (qc).A review of all qc reports from (b)(6) 2025 showed no device malfunctions, and all units passed qc for subsequent use.Turn medical confirmed that the ifu provides appropriate instruction for opening and closing the prone panels.This complaint will be closed unless additional information is provided to the company.
Event or Problem Description
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.

• Brand Name: PRONOVA-O2
• 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: 23758758
• Report Number: 3016947689-2025-00001
• Device Sequence Number: 15936221
• Product Code: IKZ
• UDI-Device Identifier: 00860006962203
• UDI-Public: 00860006962203
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 12/09/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: PTS001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2025
• Initial Report FDA Received Date: 12/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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