BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXIAIR TRANSFER MATTRESS

    MDR report key: 8300683 · Received February 4, 2019

    Report

    Report Number
    3012292104-2019-00004
    Event Type
    Malfunction
    Date Received
    February 4, 2019
    Report Date
    February 4, 2019
    Manufacturer
    GETINGE DOMINICAN REPUBLIC SA
    Product Code
    FMR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED UNDER EXEMPTION E2018019 BY THE GETINGE DOMINICAN REPUBLIC SA (REGISTRATION #3012292104) ON BEHALF OF THE IMPORTER ARJOHUNTLEIGH INC (AHUS) (REGISTRATION #1419652). AN INVESTIGATION WAS CARRIED OUT INTO THIS COMPLAINT. BASED ON THE INFORMATION RECEIVED, MAXI AIR SYSTEM WAS USED FOR PATIENT'S LATERAL TRANSFER AND WAS LEFT UNDER PATIENT'S BODY AFTER THIS PROCEDURE. ARJO WAS INFORMED THAT THE PATIENT WHO WAS LAYING ON MAXI AIR FOR A PROLONGED PERIOD OF TIME DEVELOPED A SKIN CONDITION - RASHES, BLISTERING AND SORES ON HIS BACK. AS ANY FURTHER DETAILS REGARDING THE SIZES OF SORES, THE WAY OF TREATMENT OR FURTHER PATIENT'S HEALTH STATE WERE NOT CONFIRMED, THE SEVERITY OF THE INJURY COULD NOT HAVE BEEN ASSESSED. THE PATIENT HAD SIGNIFICANT AMOUNTS OF FLUIDS COMING OFF, HOWEVER, THE STAFF WAS ACTING DILIGENT IN TERMS OF PATIENT'S POSITION ROTATION, TURNING THEM EVERY TWO HOURS. FOUR COMPLAINTS PRESENTING THE SAME ISSUE WERE REPORTED BY ONE CUSTOMER FACILITY (REGISTERED UNDER MANUFACTURER REPORT NUMBERS: 3012292104-2019-00001, 3012292104-2019-00002, 3012292104-2019-00003, 3012292104-2019-00004). MAXI AIR SYSTEM IS NOT CONSIDERED AS A THERAPEUTIC SURFACE. MAXI AIR SYSTEM IS INTENDED FOR LATERAL TRANSFER OR REPOSITIONING OF HOSPITAL AND PROFESSIONAL HEALTHCARE FACILITY PATIENTS. THE INSTRUCTION FOR USE (001-35001-EN REV 5) INDICATES THE PROCEDURE TO BE FOLLOWED AFTER THE TRANSFER COMPLETION: UNBUCKLE THE SAFETY BELTS, LOCK ALL SIDE RAILS (IF POSSIBLE), REMOVE AND DISINFECT THE AIR SUPPLY. ONCE THE TRANSFER IS COMPLETED, MAXI AIR AIR SUPPLY (PUMP) SHOULD BE DISCONNECTED FROM THE MATTRESS. AFTER PUMP'S DISCONNECTION, THE MATTRESS WILL DEFLATE AND THE PATIENT WILL LAY ON THE STANDARD MATTRESS REPLACEMENT SYSTEM. AN IMPACT OF MAXI AIR SYSTEM ON THE INTERFACE PRESSURE WAS TESTED WITHIN THE MAXI AIR COMPARATIVE PRESSURE MAPPING TEST. IT WAS CONFIRMED THAT THE PRODUCT DOES NOT NEGATIVELY IMPACT THE INTERFACE PRESSURE OF A THERAPEUTIC SURFACE WHEN REMAINING UNDER THE PATIENT. MATERIALS OF MAXI AIR WERE ALSO COMPREHENSIVELY VERIFIED IN TERMS OF BIOCOMPATIBILITY. RESULTS FROM THE SKIN IRRITATION AND ALLERGEN TESTING PROVED NEGATIVE FOR BOTH MATERIALS. IT WAS CONCLUDED THAT MATERIALS USED FOR MAXI AIR PASSED THE TEST CRITERIA AND ARE ACCEPTABLE FOR USE. ALTHOUGH IT WAS NOT POSSIBLE TO INDICATE THE EXACT REASON OF PATIENT'S SKIN CONDITION DEVELOPMENT, CIRCUMSTANCES OF THE EVENT (PROLONGED USE OF THE PRODUCT IN A HIGH HUMIDITY ENVIRONMENT AND UNKNOWN DETAILS OF TRANSFER PROCEDURE) ARE CONSIDERED TO HAVE CONTRIBUTED TO THE REPORTED PATIENT'S OUTCOME. IT HAS BEEN ESTABLISHED THAT MAXI AIR SYSTEM WAS BEING USED FOR A PATIENT TREATMENT AT THE TIME OF THE EVENT, HOWEVER, DID NOT CONTRIBUTE TO THE EVENT. THE SYSTEM WAS NOT FOUND TO HAVE MALFUNCTIONED (PERFORMING UP TO SPECIFICATION) WHEN THE EVENT TOOK PLACE.

    Description of Event or Problem · 0

    ARJO WAS NOTIFIED ABOUT 4 INCIDENTS INVOLVING ARJO MAXI AIR (AIR ASSISTED PATIENT TRANSFER SYSTEM) . IT WAS REPORTED THAT PATIENTS DEVELOPED RASHES AND BLISTERS AFTER LAYING ON THE MAXI AIR FOR EXTENDED PERIODS OF TIME. ALTHOUGH THERE IS NO INDICATION OF SERIOUS INJURY, WE REPORT THESE INCIDENTS IN ABUNDANCE OF CAUTION TAKING INTO ACCOUNT AVAILABLE INFORMATION SUCH AS PROLONG USAGE OF DEVICE AND POSSIBLE SERIOUS ALLERGIC REACTION. THIS IS FOURTH OUT OF FOUR INCIDENTS REPORTED. WE SUBMIT THIS REPORT AS A CORRECTION OF MFR REPORT NUMBER 9681684-2018-00110.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95300 MAXIAIR TRANSFER MATTRESS DEVICE, TRANSFER, PATIENT, MANUAL FMR GETINGE DOMINICAN REPUBLIC SA MAS000001

    Patients

    Seq Age Sex Outcome Treatment
    1 Other