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 03/09/2024

Event Type  Injury  

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 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
• 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: 19115706
• MDR Text Key: 340272171
• Report Number: 3013682457-2024-00008
• 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: 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
• Device Operator: Health Professional
• Device Model Number: GS2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/21/2024
• Initial Date FDA Received: 04/16/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/15/2022
• 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 Age: 39 YR
• Patient Sex: Male
• Patient Weight: 164 KG