BEUDAMED
    FDA Adverse Event Other Summary report: N

    ALPHA RESPONSE MATTRESS SYSTEM

    MDR report key: 2020146 · Received March 9, 2011

    Report

    Report Number
    1000381138-2011-00001
    Event Type
    Other
    Date Received
    March 9, 2011
    Date of Event
    January 1, 2011
    Report Date
    February 11, 2011
    Manufacturer
    ARJOHUNTLEIGH
    Product Code
    FNM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INCIDENT OCCURRED IN (B)(6) AND IS BEING REPORTED TO THE UNITED STATES AS IT IS AN IMPORTED DEVICE WITH THE POTENTIAL FOR INJURY IF THE EVENT WERE TO RECUR. THE PRODUCT HAS BEEN RETURNED FOR FURTHER INVESTIGATION; ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN CONCLUDED.

    Description of Event or Problem · 1

    PATIENT SLIPPED BETWEEN THE CELLS AND FELT HE WAS 'BOTTOMING OUT'. NO INJURY OCCURRED TO THE PATIENT IN THIS INSTANCE. HOWEVER, THIS IS BEING REPORTED BECAUSE IF THE EVENT WERE TO RECUR, THERE IS A POTENTIAL FOR MINOR PRESSURE ULCERS TO OCCUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALPHA RESPONSE MATTRESS SYSTEM ALTERNATING PRESSURE AIR MATTRESS FNM ARJOHUNTLEIGH 465003DAR

    Patients

    Seq Age Sex Outcome Treatment
    1 Other