BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALTERNATING PRESSURE MATTRESS W/LOW AIR LOSS, 36 X 80 X 10, 50L 9153647225

    MDR report key: 8073626 · Received November 15, 2018

    Report

    Report Number
    1531186-2018-00009
    Event Type
    Injury
    Date Received
    November 15, 2018
    Date of Event
    February 2, 2018
    Report Date
    October 17, 2018
    Manufacturer
    KAP MEDICAL
    Product Code
    FNM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE ALLEGATION THAT THE MA65 CAUSED/CONTRIBUTED TO THE END USER DEVELOPING PRESSURE ULCERS CANNOT BE VERIFIED. PRESSURE ULCERS ARE INJURIES TO SKIN AND UNDERLYING TISSUE RESULTING FROM PRESSURE ON THE SKIN WHEN RESTING IN A POSITION FOR AN EXTENDED PERIOD AND CAN OCCUR REGARDLESS OF THE RESTING SURFACE BEING USED. DEVELOPMENT OF PRESSURE ULCERS IS MULTIFACTORIAL. WHILE THE MA85 IS DESIGNED TO PROVIDE CHANGES IN THE DISTRIBUTION OF BODY PRESSURE, THE ALLEGED MALFUNCTION OF THE DEVICE IS ONLY ONE OF MANY CONTRIBUTING FACTORS TO THE PATIENT DEVELOPING PRESSURE ULCERS. IN ADDITION TO PRESSURE, PRIMARY CAUSES INCLUDE FRICTION AND SHEAR. INDIVIDUAL RISK FACTORS PLAY A KEY ROLE IN INCREASING THE END USER¿S SUSCEPTIBILITY TO PRESSURE SORES, EXAMPLES INCLUDE BUT ARE NOT LIMITED TO END-USER SIZE, WEIGHT, IMMOBILITY, LACK OF SENSORY PERCEPTION, INCONTINENCE, MEDICAL CONDITIONS AFFECTING BLOOD FLOW, POOR NUTRITION AND POOR HYDRATION. THE MANAGEMENT, TREATMENT, AND PREVENTION OF PRESSURE ULCERS SHOULD BE INDIVIDUALIZED AND DEPENDS ON THE END USER¿S MEDICAL HISTORY, RISK FACTORS AND PHYSICAL STATUS. IN ALL CASES, CARE IS PIVOTAL IN PRESSURE ULCER PREVENTION. EDUCATION, CLINICAL JUDGMENT AND ACTION BASED PLANNING BASED ON VULNERABILITY ARE FUNDAMENTAL FACTORS IN THE PREVENTION AND TREATMENT. IT IS VERY IMPORTANT FOR THE END USER TO REPOSITION THEMSELVES, OR TO BE REPOSITIONED ON A REGULAR BASIS. IT IS THE STANDARD OF CARE THAT THE END USER¿S CONDITION SHOULD BE MONITORED FREQUENTLY AND THE CARE PLAN SHOULD BE REVIEWED REGULARLY BY CAREGIVERS ADJUSTING FOR CHANGES IN THE END USER¿S CONDITION AND ENVIRONMENTAL FACTORS. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL RECORD WILL BE FILED.

    Description of Event or Problem · 1

    THE END USER RELATES THAT THEIR MA65 ALTERNATING PRESSURE MATTRESS WAS SINKING IN THE CENTER. THEY TRIED TO RECALIBRATE THE PUMP, BUT THE CENTER CONTINUES TO SINK. THE CALLER STATES DUE TO THE CENTER OF THE MATTRESS SINKING HE DEVELOPED A PRESSURE SORE WHICH HAS PROGRESSED TO THE POINT HIS RIGHT ISCHIUM IS VISIBLE. THE CALLER STATED IN ADDITION, HE HAD A PREEXISTING LEFT SIDE BED SORE ON HIS HIP. HIS OLD AND NEW BED SORES ARE BEING TREATED BY THE WOUND CLINIC, AND HE IS ON BED REST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    915916 ALTERNATING PRESSURE MATTRESS W/LOW AIR LOSS, 36 X 80 X 10, 50L 9153647225 MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE FNM KAP MEDICAL NA:MA65

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention