BEUDAMED
    FDA Adverse Event Death Summary report: N

    POSEY BED ALL-IN-ONE SYSTEM

    MDR report key: 1899966 · Received November 10, 2010

    Report

    Report Number
    2020362-2010-00351
    Event Type
    Death
    Date Received
    November 10, 2010
    Date of Event
    October 21, 2010
    Report Date
    October 21, 2010
    Manufacturer
    POSEY, S. DE R. L. DE C. V.
    Product Code
    FNL
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT WAS REQUESTED TO BE RETURNED FOR EVAL AND HAS NOT BEEN REC'D. THERE WAS NO PRODUCT PROBLEM RELATED TO THE PT EVENT REPORTED. MFR REFERENCES FILE (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT A CODE BLUE OCCURRED WHILE A PT WAS IN THE PRODUCT BED MODEL 8070. THE NURSING STAFF ATTEMPTED TO REACH THE PT IN ORDER TO ADMINISTER CPR, BUT THE PT PASSED AWAY. THERE WAS NO PRODUCT BED DAMAGE RELATED TO THIS EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POSEY BED ALL-IN-ONE SYSTEM FNL POSEY, S. DE R. L. DE C. V. 8070 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Death