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: 9570295 · Received January 9, 2020

    Report

    Report Number
    1531186-2020-00001
    Event Type
    Injury
    Date Received
    January 9, 2020
    Report Date
    December 10, 2019
    Manufacturer
    KAP MEDICAL
    Product Code
    FNM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE CONTROL UNIT WAS RETURNED FOR AN EXPANDED EVALUATION. UTILIZING EXISTING COMPLAINT INFORMATION, ACTUAL OBSERVATIONS, AND FUNCTIONAL TESTING OF THE RETURNED PRODUCT IN ITS ¿AS RECEIVED¿ CONDITION, THE COMPLAINT WAS NOT CONFIRMED FOR THE MATTRESS NOT FULLY INFLATING. UPON RECEIPT THE CPR VALVE WAS OPEN. THE CPR VALVE WAS CLOSED, UTILIZING THE CONTROL UNIT THE MATTRESS FULLY INFLATED AND FUNCTIONED WITH ALTERNATING PRESSURES AS DESIGNED. THE MALFUNCTION REPORTED IS CONSISTENT WITH THE CPR VALVE BEING LEFT OPEN.

    Description of Event or Problem · 0

    THE END-USERS WIFE CALLED AND ADVISED THAT HER HUSBAND HAS BED SORES ON HIS BACKSIDE DUE TO THE MA65 MATTRESS NOT WORKING PROPERLY. THE DEALER ADVISED THAT THE END-USER IS RECEIVING WOUND CARE OF CLEANING, DEBRIDEMENT, IRRIGATION, AND LIDOCAINE FOR PAIN.

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS BEING FILED IN AN ABUNDANCE OF CAUTION. THE DEALER ADVISED THE END-USER IS BED BOUND AND IS CURRENTLY STILL USING MATTRESS IN A PRIVATE HOME. TECHNICIANS TESTED THE MATTRESS AND NO LEAKS WERE FOUND. BASED ON THE LIMITED INFORMATION PROVIDED, A DEVICE MALFUNCTION CANNOT BE CONFIRMED. THE COMPLAINT COULD NOT BE VERIFIED, AND THE UNDERLYING CAUSE COULD NOT BE DETERMINED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL RECORD WILL BE FILED.

    Description of Event or Problem · 1

    THE END-USERS WIFE CALLED AND ADVISED THAT HER HUSBAND HAS BED SORES ON HIS BACKSIDE DUE TO THE MA65 MATTRESS NOT WORKING PROPERLY. THE DEALER ADVISED THAT THE END-USER IS RECEIVING WOUND CARE OF CLEANING, DEBRIDEMENT, IRRIGATION, AND LIDOCAINE FOR PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35121 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