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 09/08/2022

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.Two pressure injuries were observed on the patient.A sacrum dti evolved to a stage 3 injury on (b)(6) 2022.A sacrum unstageable with dtpi debrided on (b)(6) 2022 to a stage 4.Evaluation of guardian data noted no indications of device malfunction or significant gaps in therapy.

• 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: 19018693
• MDR Text Key: 339099042
• Report Number: 3013682457-2024-00005
• 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: 10/02/2022
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 84 YR
• Patient Sex: Male
• Patient Weight: 92 KG