MAUDE Adverse Event Report: TURNCARE, INC. GUARDIAN 2 SYSTEM; ALTERNATING PRESSURE SUPPORT SURFACE

Model Number	G2S
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Pressure Sore/Ulcer (2326)
Date of Event	04/10/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient was admitted to the hospital (b)(6) mar.On (b)(6) 2025 a stage 3 pressure injury was observed on the buttocks by the facility.There was no indication of injury progression or what, if any, additional treatment was required for the pressure injury.Review of the guardian system controller data noted there were user facing events related to potential leakage of air within the system in the days leading up to the injury discovery.These alerts prompt the user to address the issue, including changing out of the surface if necessary.Data from the system indicated that some of these leak alert events went unaddressed for excess periods of time (> 3.5 hours and > 10.5 hours).In addition, some leak alert events were cleared by the user without changing of the surface.If any further relevant information becomes available, an update to this report will be filed.
Additional Manufacturer Narrative
This injury was discovered by turncare through a review of hospital hapi report information.There was no allegation from the customer that the guardian system caused or contributed to the pressure injury event, and it cannot be determined the leak alert events caused or contributed.

• Brand Name: GUARDIAN 2 SYSTEM
• Common Device Name: ALTERNATING PRESSURE SUPPORT SURFACE
• Manufacturer (Section D): TURNCARE, INC.; 230 west parkway, unit 6; pompton plains NJ 07444
• Manufacturer (Section G): TURNCARE, INC.; 230 west parkway, unit 6; pompton plains NJ 07444
• Manufacturer Contact: richard kalita ; 230 west parkway, unit 6; pompton plains, NJ 07444
• MDR Report Key: 22554460
• Report Number: 3013682457-2025-00003
• Device Sequence Number: 18566920
• Product Code: FNM
• UDI-Device Identifier: 00860001236453
• UDI-Public: (01)00860001236453
• 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): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/03/2025

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 Model Number: G2S
• Device Catalogue Number: GS-2.5-C
• 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: 05/06/2025
• Initial Report FDA Received Date: 07/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/01/2022
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown