FDA Adverse Event Injury Summary report: N

GUARDIAN 2 SYSTEM

MDR report key: 22554460 · Received July 21, 2025

Report

Report Number: 3013682457-2025-00003
Event Type: Injury
Date Received: July 21, 2025
Date of Event: April 10, 2025
Report Date: June 3, 2025
Manufacturer: TURNCARE, INC.
Product Code: FNM
UDI-DI: 00860001236453
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: PA, US
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

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, AND IT CANNOT BE DETERMINED THE LEAK ALERT EVENTS CAUSED OR CONTRIBUTED.

Description of Event or Problem · 0

PATIENT WAS ADMITTED TO THE HOSPITAL (B)(6) MAR. ON (B)(6) 2025 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 THERE WERE USER FACING EVENTS RELATED TO POTENTIAL LEAKAGE OF AIR WITHIN THE SYSTEM IN THE DAYS LEADING UP TO THE INJURY DISCOVERY. THESE ALERTS PROMPT THE USER TO ADDRESS THE ISSUE, INCLUDING CHANGING OUT OF THE SURFACE IF NECESSARY. DATA FROM THE SYSTEM INDICATED THAT SOME OF THESE LEAK ALERT EVENTS WENT UNADDRESSED FOR EXCESS PERIODS OF TIME (> 3.5 HOURS AND > 10.5 HOURS). IN ADDITION, SOME LEAK ALERT EVENTS WERE CLEARED BY THE USER WITHOUT CHANGING OF THE SURFACE. IF ANY FURTHER RELEVANT INFORMATION BECOMES AVAILABLE, AN UPDATE TO THIS REPORT WILL BE FILED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
2036448	GUARDIAN 2 SYSTEM	ALTERNATING PRESSURE SUPPORT SURFACE	FNM	TURNCARE, INC.	G2S		00860001236453

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Unknown