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

Model Number	GS2
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Pressure Sore/Ulcer (2326)
Date of Event	02/15/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient was initially diagnosed with an unstageable pressure injury on (b)(6) 2024.The last assessment on (b)(6) 2024 classified the injury as a stage 3.The location of the injury is on the natal cleft.The reporting facility indicated they used a topical application and dressing to treat the pressure injury.The reporting facility indicated they do not believe the guardian device caused or contributed to the injury observed on the patient.Investigation of the available information from the guardian system noted 8 incidences where the using facility did not utilize the pause feature of the device for 12 consecutive hours, which can lead to enhancer migration.On (b)(6) 2024 therapy was paused and then resumed with the enhancer potentially mispositioned.This is based on a review of the guardian system event log information, noting "suspected patient misposition" events.The device continued to log several misposition events until the patient was discharged on (b)(6) 2024, resulting in 48 hours of less than optimal therapy.An update will be filed if any further relevant information becomes available.
Additional Manufacturer Narrative
Investigation was conducted on the reported information and from the data collected by the guardian device.

• 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: 18986318
• Report Number: 3013682457-2024-00002
• Device Sequence Number: 11480090
• 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: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/27/2024

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: 02/27/2024
• Initial Report FDA Received Date: 03/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/01/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown
• Patient Weight: 88 KG