BEUDAMED
    FDA Adverse Event Other Summary report: N

    ALPHA RESPONSE

    MDR report key: 3952426 · Received June 30, 2014

    Report

    Report Number
    1419652-2014-00169
    Event Type
    Other
    Date Received
    June 30, 2014
    Date of Event
    April 8, 2014
    Report Date
    April 8, 2014
    Manufacturer
    ARJOHUNTLEIGH POLSKA SP. Z O.O
    Product Code
    FNM
    Report Source
    Distributor report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER ADVISED MATTRESS KEEPS OVER INFLATING CAUSING HIS LEGS TO FALL OFF THE MATTRESS AND GET CAUGHT IN BETWEEN THE MATTRESS AND RAILS. THE TECHNICIAN ADVISED NO OBVIOUS FAULT. REFERENCE MFR # 3007420694-2014-00071.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379092 ALPHA RESPONSE FNM ARJOHUNTLEIGH POLSKA SP. Z O.O 465001DAR

    Patients

    Seq Age Sex Outcome Treatment
    1 Other