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

Model Number	GS2
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	Pressure Sore/Ulcer (2326)
Date of Event	07/08/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient was admitted to the hospital on (b)(6) 2024.On (b)(6) 2024 a stage 3 pressure injury was observed on the buttocks by the facility.There was no indication of injury progression or what, if any, additional treatment was required for the pressure injury.Review of the guardian system controller data noted "leak alert" events prior to the injury event occurrence, resulting in the controller prompting the healthcare professional to take action.Replacement of the bed surface was delayed by the healthcare professional based on their judgment of patient conditions and treatment options.It was reported the patient had an acute respiratory illness, experienced pain and oxygen desaturation with movement, and was refusing standard patient turn practices.The associated controller was eventually returned to turncare for service at which time a manifold valve was replaced.If any further relevant information becomes available, an update to this report will be filed.
Additional Manufacturer Narrative
This injury was discovered by turncare through a review of hospital hapi report information.There was no allegation from the customer that the guardian system caused or contributed to the pressure injury event.

• Brand Name: GUARDIAN 2 SYSTEM
• Common Device Name: 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: 20113693
• Report Number: 3013682457-2024-00012
• Device Sequence Number: 6968766
• Product Code: FNM
• UDI-Device Identifier: 00860001236453
• UDI-Public: (01)00860001236453
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/30/2024

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
• Operator of Device: Health Professional
• Device Model Number: GS2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2024
• Initial Report FDA Received Date: 08/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown