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

Model Number	GS2
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Pressure Sore/Ulcer (2326)
Date of Event	04/05/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation was conducted on the reported information and from the data collected by the guardian device.Investigation of the guardian system data indicates the user cleared multiple pinch alerts without resolving the issue.However, it cannot be determined whether this caused or contributed to the injury observed.
Event or Problem Description
Patient was admitted to the hospital on (b)(6) 2024.On 05-apr-2024 a stage 3 pressure injury was observed on the natal cleft.It was noted the injury progressed from a masd to a stage 3 pressure injury.No further details were reported regarding the reason for patient hospital admission, or with regards to outcomes from the stage 3 injury observed.Review of the guardian system data noted multiple pinch alert "airflow blocked" events, accounting for a total of 14.68 hours of gaps in therapy (27% of total gaps in therapy) from admission to injury discovery.It was also noted the pinch alerts were cleared multiple times by the user without resolution.An update will be filed if any further relevant information becomes available.

• 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: 19373609
• Report Number: 3013682457-2024-00010
• Device Sequence Number: 7724732
• 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): 05/22/2024

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/01/2024
• Initial Report FDA Received Date: 05/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/01/2023
• 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