BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INVACARE MICROAIR ALTERNATING PRESSURE, LATERAL ROTATION MATTRESS

    MDR report key: 8052213 · Received November 8, 2018

    Report

    Report Number
    1531186-2018-00008
    Event Type
    Injury
    Date Received
    November 8, 2018
    Date of Event
    August 25, 2018
    Report Date
    October 19, 2018
    Manufacturer
    KAP MEDICAL
    Product Code
    FNM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2018, THE MA90ZP POWER UNIT (SERIAL NUMBER (B)(4)) WAS RETURNED TO INVACARE AND WAS EVALUATED. DURING THE BENCH TEST, THE COMPONENT OPERATED PROPERLY. THIS IS CONSISTENT WITH THE FACT THAT REPLACING THE POWER UNIT DID NOT CORRECT THE REPORTED ISSUE. THE MA90Z MATTRESS HAS NOT BEEN RETURNED TO INVACARE. ANY FAILURE WITH THIS COMPONENT HAS NOT BEEN CONFIRMED. SHOULD IT BE RECEIVED IN THE FUTURE, A SUPPLEMENTAL RECORD WILL BE FILED.

    Description of Event or Problem · 0

    THE DEALER REPORTED THAT THE PATIENT ALLEGED THAT WHEN THE MA90Z MATTRESS IS IN MAX INFLATE MODE, ONLY EVERY OTHER TUBE IS FILLING UP, AND THE TUBES THAT ARE FILLING ARE ONLY COMPLETELY FILLING ON THE RIGHT SIDE; THE LEFT SIDE COMPRESSES WHEN FORCE IS APPLIED. THE PATIENT HAS PREEXISTING PRESSURE SORES, WHICH REQUIRE THE THERAPEUTIC VALUE OF THE MA90Z MATTRESS, AND THE PATIENT¿S FAMILY ALLEGED THAT THEY HAVE WORSENED BECAUSE OF THE ISSUES WITH THE MATTRESS. OVER A PERIOD OF TWO MONTHS, THE PATIENT¿S PRESSURE SORES HAVE PROGRESSED TO A TUNNELING STAGE 4 AND REQUIRE A WOUND VAC TO ASSIST WITH HEALING.

    Additional Manufacturer Narrative · 1

    AT THIS TIME, THE UNDERLYING CAUSE OF THE MATTRESS NOT INFLATING PROPERLY CANNOT BE DETERMINED. THE PATIENT¿S FAMILY CHECKED THE CELLS AND FOUND NO HOLES, AND THEY CHECKED ALL CONNECTIONS AND FOUND NO LEAKS. ATTEMPTS HAVE BEEN MADE TO CORRECT THE ISSUE. FIRST, THE POWER UNIT WAS REPLACED, BUT THE LEFT SIDE OF THE MATTRESS STILL WOULD NOT INFLATE. THE PATIENT¿S FAMILY PROPPED UP THE PATIENT WITH PILLOWS ON THE LEFT SIDE, TO COMPENSATE FOR THE SAGGING MATTRESS, BUT THEN THE PATIENT DEVELOPED A HEAT RASH, WHICH WAS TREATED WITH AN OINTMENT FROM HER WOUND CARE DOCTOR. NEXT, THE MANIFOLD WAS REPLACED, BUT THE UNIT WAS STILL NOT COMPLETELY FILLING THE CELLS. THE DEALER¿S REPAIR TECHNICIAN ADVISED THAT THE MANIFOLD WAS POPPING OUT OF THE CELL. THEY WERE ADVISED THAT IT WAS ACCEPTABLE TO PLACE ZIP TIES ON THE MANIFOLD, AS LONG AS IT DID NOT MODIFY THE CONNECTION, UNTIL THE ENTIRE UNIT WAS ABLE TO BE REPLACED. AN ORDER FOR THE REPLACEMENT OF THE MA90Z SYSTEM WAS INITIATED BUT WAS ON BACKORDER. IN THE MEANTIME, AN MA55 MATTRESS WAS SENT TO THE PATIENT, AND THE PATIENT'S FAMILY WAS ADVISED THAT THEY WOULD NEED TO MANUALLY TURN THE PATIENT, SINCE THE MA55 DOES NOT OFFER LATERAL ROTATION. ON 10/23/2018, THE MA95Z MATTRESS BECAME AVAILABLE AND WAS SENT TO THE PATIENT, INSTEAD OF THE MA90Z MATTRESS. THE MA95Z HAS A HIGHER THERAPEUTIC VALUE. THE ALLEGATION THAT THE MATTRESS CAUSED/CONTRIBUTED TO THE WORSENING OF THE PATIENT'S PREEXISTING PRESSURE SORES CANNOT BE VERIFIED. PRESSURE SORES 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 MA90Z MATTRESS 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 SORES. IN ADDITION TO PRESSURE, PRIMARY EXTERNAL CAUSES INCLUDE FRICTION AND SHEAR. INDIVIDUAL RISK FACTORS ALSO PLAY A KEY ROLE IN INCREASING THE PATIENT'S SUSCEPTIBILITY; EXAMPLES INCLUDE, BUT ARE NOT LIMITED TO: PATIENT 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 SORES SHOULD BE INDIVIDUALIZED AND DEPENDS ON THE PATIENT¿S MEDICAL HISTORY, RISK FACTORS AND PHYSICAL STATUS. IN ALL CASES, CARE IS PIVOTAL IN PRESSURE SORE PREVENTION. EDUCATION, CLINICAL JUDGEMENT, AND ACTION-BASED PLANNING BASED ON VULNERABILITY ARE FUNDAMENTAL FACTORS IN THE PREVENTION AND TREATMENT OF PRESSURE SORES. IT IS VERY IMPORTANT FOR THE PATIENT TO REPOSITION THEMSELVES, OR TO BE REPOSITIONED, ON A REGULAR BASIS. IT IS THE STANDARD OF CARE THAT THE PATIENT¿S CONDITION SHOULD BE MONITORED FREQUENTLY, AND THEIR INDIVIDUALIZED CARE PLAN SHOULD BE REVIEWED REGULARLY BY CAREGIVERS, ADJUSTING FOR CHANGES IN THE PATIENT¿S CONDITION AND ENVIRONMENTAL FACTORS. IT IS EXPECTED THAT THE DEVICE WILL BE RETURNED TO INVACARE FOR EVALUATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL RECORD WILL BE FILED.

    Description of Event or Problem · 1

    THE DEALER REPORTED THAT THE PATIENT ALLEGED THAT WHEN THE MA90Z MATTRESS IS IN MAX INFLATE MODE, ONLY EVERY OTHER TUBE IS FILLING UP, AND THE TUBES THAT ARE FILLING ARE ONLY COMPLETELY FILLING ON THE RIGHT SIDE; THE LEFT SIDE COMPRESSES WHEN FORCE IS APPLIED. THE PATIENT HAS PREEXISTING PRESSURE SORES, WHICH REQUIRE THE THERAPEUTIC VALUE OF THE MA90Z MATTRESS, AND THE PATIENT¿S FAMILY ALLEGED THAT THEY HAVE WORSENED BECAUSE OF THE ISSUES WITH THE MATTRESS. OVER A PERIOD OF TWO MONTHS, THE PATIENT¿S PRESSURE SORES HAVE PROGRESSED TO A TUNNELING STAGE 4 AND REQUIRE A WOUND VAC TO ASSIST WITH HEALING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    891334 INVACARE MICROAIR ALTERNATING PRESSURE, LATERAL ROTATION MATTRESS MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE FNM KAP MEDICAL MA90Z

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention