FDA Adverse Event Injury Summary report: N

GUARDIAN 2 SYSTEM

MDR report key: 19181350 · Received April 25, 2024

Report

Report Number: 3013682457-2024-00009
Event Type: Injury
Date Received: April 25, 2024
Date of Event: April 3, 2024
Report Date: April 25, 2024
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

INVESTIGATION WAS CONDUCTED ON THE REPORTED INFORMATION AND FROM THE DATA COLLECTED BY THE GUARDIAN DEVICE. INVESTIGATION OF THE GUARDIAN SYSTEM DATA SUGGESTS THE PATIENT MAY HAVE BEEN MISPOSITIONED ON THE SUPPORT SURFACE. HOWEVER, IT CANNOT BE DETERMINED WHETHER THIS CAUSED OR CONTRIBUTED TO THE INJURY OBSERVED.

Description of Event or Problem · 0

PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2024. ON (B)(6) 2024 A DTI WAS OBSERVED. IT WAS NOTED THE PATIENT WAS CONTRACTED WITH MINIMAL MOVEMENT BY SELF IN AND OUT OF A CHAIR WITH SLING. NO FURTHER DETAILS WERE REPORTED REGARDING THE REASON FOR PATIENT HOSPITAL ADMISSION, OR WITH REGARDS TO OUTCOMES FROM THE DTI OBSERVED. THE HOSPITAL CONTACT INDICATED THEY DID NOT BELIEVE THE GUARDIAN SYSTEM CAUSED OR CONTRIBUTED TO THE INJURY EVENT. REVIEW OF THE GUARDIAN SYSTEM DATA NOTED EVENTS OF NO INTERACTION WITH THE GUARDIAN SYSTEM FOR AT LEAST 48 HOURS, WHICH MEANS THERAPY WASN'T PAUSED FOR PATIENT CARE/TURNING & POSITIONING. NUMEROUS LOGGED EVENTS OF "NO PATIENT DETECTED" AND "SUSPECTED PATIENT MISPOSITION" WERE ALSO NOTED. AN UPDATE WILL BE FILED IF ANY FURTHER RELEVANT INFORMATION BECOMES AVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1161892	GUARDIAN 2 SYSTEM	ALTERNATING PRESSURE SUPPORT SURFACE	FNM	TURNCARE, INC.	GS2		00860001236453

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Unknown