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

Model Number GS2

Device Problem Malposition of Device (2616)

Patient Problem Pressure Sores (2326)

Event Date 02/15/2024

Event Type  Injury  

Event 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.

Manufacturer Narrative

Investigation was conducted on the reported information and from the data collected by the guardian device.

• 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: 18986318
• MDR Text Key: 338704113
• Report Number: 3013682457-2024-00002
• 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: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2024
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/27/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/01/2022
• 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 Weight: 88 KG