BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROHO DRY FLOATATION MATTRESS OVERLAY SYSTEM

    MDR report key: 4522899 · Received February 12, 2015

    Report

    Report Number
    1419507-2015-00001
    Event Type
    Injury
    Date Received
    February 12, 2015
    Date of Event
    January 2, 2014
    Report Date
    February 12, 2015
    Manufacturer
    ROHO, INC.
    Product Code
    IKY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ROHO HAS CONDUCTED AN INVESTIGATION AND WITH INFORMATION PROVIDED BY THEIR DISTRIBUTOR, SUMED, HAS CONCLUDED THAT THE INCIDENT WAS USER ERROR BASED ON INFORMATION IN THIS REPORT AND THE FOLLOWING: THE PATIENT HAS VERY COMPLEX PMH AND MOVING AND HANDLING ISSUES, WHICH THE FACILITY TEAM DID NOT REVIEW IN ACCORDANCE WITH FACILITY POLICIES. THE PATIENT DEVELOPED A STAGE 3 PRESSURE SORE, WHICH WAS DIAGNOSED WHILE THE ROHO MATTRESS OVERLAY WAS IN USE. THE FACILITY'S REPORT INDICATED THAT THE ROHO MATTRESS OVERLAY WAS NOT SET UP CORRECTLY (OVER-INFLATED WHILE IN USE) AND TWO PIECES WERE NOT CONNECTED AS THEY SHOULD HAVE BEEN. THE FACILITY REPORTED THE PATIENT NEEDED REGULAR CHECKING AND HAD NOT BEEN CHECKED FOR A 10 DAY PERIOD. IT HAS BEEN REPORTED BY THE LEAD TISSUE VIABILITY NURSE AT THE FACILITY THAT THE PATIENT SHOULD NEVER HAVE BEEN CHANGED FROM A DYNAMIC SYSTEM. THE LEAD TISSUE VIABILITY NURSE AT THE FACILITY HAD TO CANCEL SPECIALIST TRAINING THAT HAD BEEN SCHEDULED FOR (B)(4) 2013 DUE TO PRESSURES FROM SENIOR MANAGERS WITHIN THE TRUST. SUMED WILL WORK WITH THE FACILITY TO SCHEDULE A NEW TRAINING SESSION FOR THE STAFF ON PROPER USE OF ROHO MATTRESS OVERLAYS. A COMPREHENSIVE TRAINING PLAN WILL BE FINALIZED BEFORE THE END OF (B)(4) 2015.

    Description of Event or Problem · 1

    THE PATIENT DEVELOPED A STAGE 3 PRESSURE SORE, WHICH WAS DIAGNOSED WHILE THE ROHO MATTRESS OVERLAY WAS IN USE. THE FACILITY'S NOTES INDICATED THAT THE PATIENT WAS PREVIOUSLY ON A DYNAMIC MATTRESS AND THAT THERE IS A HISTORY OF THREE OF THE SAME BRAND DYNAMIC MATTRESSES FAILING (DEFLATING). THE DYNAMIC MATTRESSES WERE NOT MANUFACTURED BY ROHO, INC. IN THE PERIOD RUNNING UP TO (B)(6) THERE HAD BEEN THE THIRD FAILURE OF THIS BRAND AND A DECISION TAKEN BY THE FACILITY WAS TO USE A ROHO DRY FLOATATION MATTRESS OVERLAY SYSTEM (ROHO MATTRESS OVERLAY) IN CASE THERE WAS ANOTHER FAILURE OF THE DYNAMIC MATTRESS DURING A PERIOD WHEN THERE WAS REDUCED STAFFING. THE FACILITY'S REPORT INDICATED THAT THE ROHO MATTRESS OVERLAY WAS NOT SET UP CORRECTLY (OVER-INFLATED WHILE IN USE) AND TWO PIECES WERE NOT CONNECTED AS THEY SHOULD HAVE BEEN. THE FACILITY ACKNOWLEDGED THE PATIENT NEEDED REGULAR CHECKING AND HAD NOT BEEN CHECKED FOR A 10 DAY PERIOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104173 ROHO DRY FLOATATION MATTRESS OVERLAY SYSTEM NON-POWERED MATTRESS OVERLAY IKY ROHO, INC. MATTSYS

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention