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 04/03/2024

Event Type  Injury  

Manufacturer Narrative

Investigation was conducted on the reported information and from the data collected by the guardian device.Investigation of the guardian system data suggests the patient may have been mispositioned on the support surface.However, it cannot be determined whether this caused or contributed to the injury observed.

Event Description

Patient was admitted to the hospital on (b)(6) 2024.On (b)(6) 2024 a dti was observed.It was noted the patient was contracted with minimal movement by self in and out of a chair with sling.No further details were reported regarding the reason for patient hospital admission, or with regards to outcomes from the dti observed.The hospital contact indicated they did not believe the guardian system caused or contributed to the injury event.Review of the guardian system data noted events of no interaction with the guardian system for at least 48 hours, which means therapy wasn't paused for patient care/turning & positioning.Numerous logged events of "no patient detected" and "suspected patient misposition" were also noted.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: 19181350
• MDR Text Key: 341040004
• Report Number: 3013682457-2024-00009
• 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: 04/25/2024

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: 04/03/2024
• Initial Date FDA Received: 04/25/2024
• 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 Weight: 49 KG