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

Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/24/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The pronova-o2 bed (serial #(b)(6)) was stuck in supine at 16 degrees and would not go to zero.We needed to switch beds.When trying to get the patient out of this bed and into the other bed, the side rail on the right arm would not move so we had to rearrange room and move him out of the left side of his bed into the new bed.

• 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
• MDR Report Key: 20460796
• Report Number: 20460796
• Device Sequence Number: 15149647
• Product Code: IKZ
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 07/25/2024
• Report Date (Section F): 07/25/2024

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/16/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 31 YR
• Patient Sex: Unknown
• Date Report Sent to FDA: 07/25/2024