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

Model Number	GS2
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pressure Sore/Ulcer (2326)
Date of Event	12/07/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report is being submitted based on a retrospective review (reference rca # (b)(4).Investigation was conducted on the reported information and from the data collected by the guardian device available at the time.
Event or Problem Description
Patient was admitted on (b)(6) 2022.Patient was discharged off the guardian system on (b)(6) 2022 and not re-enrolled for the duration of their stay.On (b)(6) 2022, a stage 2 pressure injury was observed to the sacral region, which progressed to a stage 3 injury as of (b)(6) 2022.No further information on treatment of the pressure injury was provided.It is noted the pressure injury was observed two days after the patient was discharged off the guardian system without re-enrollment.Evaluation of guardian data noted several gaps in therapy, including several gaps due to patient discharges from the system (greater than 92 total hours).There were no indications of device malfunction.

• 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: 19018709
• Report Number: 3013682457-2024-00007
• Device Sequence Number: 7981265
• Product Code: FNM
• UDI-Device Identifier: 00860001236453
• UDI-Public: (01)00860001236453
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Type of Report: Initial
• Report Date (Section B): 04/02/2024

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
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2022
• Initial Report FDA Received Date: 04/02/2024
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown