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

Model Number	GS2
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	Pressure Sore/Ulcer (2326)
Date of Event	01/09/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation was conducted on the reported information and from the data collected by the guardian device.The data collected noted the leak alert condition, which went unresolved until the patient was transferred despite attempts by the turncare team to contact the bedside nurse.Note: access to emdr submission process in the production environment was granted to turncare on 3/14/2024 (reference esg ticket (b)(4)).
Event or Problem Description
Patient was diagnosed with a stage 3 pressure injury on the buttocks.There was no indication from the using facility whether further treatment or intervention was required as a result.There was also no documentation of the injury getting worse, or that any additional complications occurred as a result of the stage 3 pressure injury.Investigation of the available information noted a leak alert registered in the guardian device during use by this patient, and the system continued to alert until the patient was transferred despite attempts by the turncare team to contact the bedside nurse.The guardian device was not returned for further investigation.An update will be filed if any further relevant information becomes available.

• Brand Name: GUARDIAN 2 SYSTEM
• Common Device Name: ALTERNATING PRESSSURE 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: 18914923
• Report Number: 3013682457-2024-00001
• Device Sequence Number: 6759893
• 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: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/15/2024

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2024
• Initial Report FDA Received Date: 03/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/01/2022
• 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 Age: 85 YR
• Patient Sex: Male
• Patient Weight: 84 KG