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	03/09/2024
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 into the guardian system data for the 48 hours preceding the injury suggests the enhancer was not positioned properly underneath the patient.The investigation conducted by turncare revealed no evidence of defects, failures, or malfunctions of the device.
Event or Problem Description
Patient was admitted to the hospital with pancytopenia on (b)(6) 2024.Patient was initially diagnosed with a dti on 09-mar-2024, which evolved to a stage 3 injury assessed on 15-mar-2024.The reported escalation to stage 3 occurred 4 days after the patient was no longer enrolled on the guardian system.Initial report from the hospital contact indicated "skin indentations from the turncare mat were palpable upon rolling the patient".The initial belief from the hospital was the indentations were from the tubing of the enhancer.Additional follow up from the hospital wound care rn could not be certain whether the wound was caused by the turncare device.Based on a review of injury photos, turncare medical personnel do not believe the wound was caused by the enhancer tubing since the nature of the wound is not consistent with what would be expected from one caused by impression from the enhancer tubing.When used according to turncare standard education and best practice, the tubing does not come in contact with the patient's skin.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: 19115706
• Report Number: 3013682457-2024-00008
• Device Sequence Number: 7819759
• 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): 04/16/2024

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: 03/21/2024
• Initial Report FDA Received Date: 04/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/15/2022
• 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 Age: 39 YR
• Patient Sex: Male
• Patient Weight: 164 KG