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	08/01/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient was admitted on (b)(6) 2023.The patient weight range selection for the guardian device was 81-91kg.On (b)(6) 2023, a dti was identified on the patient.There was no further indication of injury progression or what treatment, if any, was required to treat the dti.Evaluation of guardian data leading up to the dti discovery was performed.A total delay of 19.5 hours in time to initiate therapy was noted, and potentially 12.3 hours of gaps in therapy was also noted.No further information was provided regarding this incident.
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.

• 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: 19018692
• Report Number: 3013682457-2024-00004
• Device Sequence Number: 12805110
• 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
• 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: 09/25/2023
• 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