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

Model Number GS2

Device Problem Gas/Air Leak (2946)

Patient Problem Pressure Sores (2326)

Event Date 01/09/2024

Event Type  Injury  

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 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
• Type of Device: 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
• MDR Text Key: 337793787
• Report Number: 3013682457-2024-00001
• 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: 03/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2024
• 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
• Date Manufacturer Received: 02/06/2024
• 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 Age: 85 YR
• Patient Sex: Male
• Patient Weight: 84 KG