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

Model Number GS2

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pressure Sores (2326)

Event Date 12/07/2022

Event Type  Injury  

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 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
• Type of Device: 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
• MDR Text Key: 339098602
• Report Number: 3013682457-2024-00007
• Device Sequence Number: 1
• Product Code: FNM
• UDI-Device Identifier: 00860001236453
• UDI-Public: (01)00860001236453
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: GS2
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/15/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1