BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUARDIAN 2 SYSTEM

    MDR report key: 19510673 · Received June 11, 2024

    Report

    Report Number
    3013682457-2024-00011
    Event Type
    Injury
    Date Received
    June 11, 2024
    Date of Event
    May 28, 2024
    Report Date
    June 11, 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 INDICATES A TERMINAL BATTERY SHUTDOWN OCCURRED DESPITE PROPER ALERT BY THE SYSTEM TO THE USER. HOWEVER, IT CANNOT BE DETERMINED WHETHER THIS USE ERROR CAUSED OR CONTRIBUTED TO THE INJURY OBSERVED. THERE WERE NO INDICATIONS OF DEVICE FAILURE OR MALFUNCTION.

    Description of Event or Problem · 0

    PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2024. ON (B)(6) 2024 AN EVOLVING DTI WOUND WAS OBSERVED ON THE COCCYX THAT OPENED TO A STAGE 3 PRESSURE INJURY. THE WOUND WAS CLASSIFIED AS A PSI 03 INJURY BY THE CUSTOMER. THE CUSTOMER REPORTED USE OF TOPICAL APPLICATION AND DRESSING TO TREAT THE WOUND. IT WAS NOTED THE INJURY DID NOT PROGRESS FROM ITS INITIAL DISCOVERY. REPORTED DETAILS FROM THE CUSTOMER: "DISCHARGED 58 YR OLD 31 DAYS ADMITTED WITH AN ICH AND RT CRANIOTOMY. NEEDING A TACH AND PEG TUBE PLACEMENT. NEEDING SEVERAL STAYS IN ICU (B)(6) AND BACK ON (B)(6). PATIENT WITH MORBID OBESITY. 279 LBS FLACCID ON HIS LF SIDE. WOUND CONSULT PLACED (B)(6) BY NURSE AND SEEN (B)(6). WOUND ON COCCYX WITH EVOLVING DTI THAT OPENED INTO A STAGE 3. NUTRITION CONSULTED (B)(6). ALL INTERVENTIONS IN PLACE. ON TURNCARE, SPRY PILLOWS, WITH A FOLEY UNTIL DAY OF DISCHARGE, AND OUT OF BED TO CHAIR. TURNED AND REPOSITIONED AS OFTEN AS SAFELY POSSIBLE DUE TO DESATTING WHEN REPOSITIONING." REVIEW OF THE GUARDIAN SYSTEM DATA NOTED THE CONTROLLER USED FOR THIS PATIENT HAD A TERMINAL BATTERY SHUTDOWN OF GREATER THAN 20 HOURS, STARTING THE DAY PRIOR TO INJURY IDENTIFICATION AND PATIENT WAS RE-ENROLLED ON TURNCARE THE DAY THE PRESSURE INJURY WAS IDENTIFIED. THE END USER WAS ALERTED APPROPRIATELY WITH BOTH AUDIBLE AND VISIBLE ALERTS OF THE LOW BATTERY. OTHER SIGNIFICANT GAPS IN THERAPY INCLUDE MULTIPLE "ENHANCER DISCONNECTED" EPISODES, WHICH MEANS THE PATIENT WAS NOT RECEIVING ANY THERAPY DURING THESE TIME PERIODS (CUMULATIVELY 31+ HOURS FROM ADMISSION DATE TO INJURY IDENTIFICATION DATE). AN UPDATE WILL BE FILED IF ANY FURTHER RELEVANT INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1295020 GUARDIAN 2 SYSTEM ALTERNATING PRESSURE SUPPORT SURFACE FNM TURNCARE, INC. GS2 00860001236453

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male Hospitalization