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 08/01/2023

Event Type  Injury  

Event Description

Patient was admitted on (b)(6) 2023.The patient weight range selection for the guardian device was 81-91kg.On (b)(6) 2023, a dti was identified on the patient.There was no further indication of injury progression or what treatment, if any, was required to treat the dti.Evaluation of guardian data leading up to the dti discovery was performed.A total delay of 19.5 hours in time to initiate therapy was noted, and potentially 12.3 hours of gaps in therapy was also noted.No further information was provided regarding this incident.

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: 19018692
• MDR Text Key: 339102240
• Report Number: 3013682457-2024-00004
• 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: 09/25/2023
• 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