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

Model Number	GS2
Medical Device Problem Code	Failure to Run on Battery (1466)
Health Effect - Clinical Code	Pressure Sore/Ulcer (2326)
Date of Event	01/29/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This injury was discovered by turncare through a review of (b)(6) report information.There was no allegation from the customer that the guardian system caused or contributed to the pressure injury event.
Event or Problem Description
Patient was admitted to the hospital on (b)(6) 2025.On (b)(6) 2025 a dti was observed on the ischium 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 showed incidences of terminal battery shutdowns of the controller, resulting in times where the guardian system was not running.The terminal battery events occurred if the controller was unplugged from ac power, and when this occurred the terminal battery software warnings/alerts, prompting action to the user, were operating properly.When connected to ac power, the controller operated continually without issue.The associated controller was eventually returned to turncare for service at which time the power supply was replaced.If any further relevant information becomes available, an update to this report will be filed.

• 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: 21503732
• Report Number: 3013682457-2025-00002
• Device Sequence Number: 7901934
• 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): 03/03/2025

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: GS2
• Device Catalogue Number: GS-2.5-C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2025
• Initial Report FDA Received Date: 03/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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