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 09/10/2022

Event Type  Injury  

Event Description

Patient was admitted on (b)(6) 2022.A dtpi was observed in the sacrum/natal cleft area on (b)(6) 2022.No further information on treatment of the dtpi was provided.Evaluation of guardian data noted several gaps in therapy, including a total of 19 hours 5 mins due to enhancer disconnect.This included 4 episodes, totaling 8hrs 22 mins between (b)(6) 2022.It was also noted the incorrect patient weight range was selected (selected range was 126-136kg).There were no indications of device malfunction.

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.

• 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: 19018710
• MDR Text Key: 339099421
• Report Number: 3013682457-2024-00006
• 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

• 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
• Initial Date Manufacturer Received: 09/25/2022
• Initial Date FDA Received: 04/02/2024
• 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 Age: 71 YR
• Patient Sex: Female
• Patient Weight: 176 KG