BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADEL OBS

    MDR report key: 2253892 · Received August 11, 2011

    Report

    Report Number
    1831750-2011-08554
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Date of Event
    July 15, 2011
    Report Date
    July 15, 2011
    Manufacturer
    STRYKER MEDICAL
    Product Code
    HDD
    PMA / PMN Number
    K950889
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY SERVICE REPORT THAT THE BED HAD NO POWER DUE TO A BLOWN FUSE IN THE POWER SUPPLY. THE CUSTOMER COULD NOT DETERMINE IF THERE WAS PT INVOLVEMENT OR IF THERE WERE ADVERSE CONSEQUENCES TO REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADEL OBS LABOR AND DELIVERY BED HDD STRYKER MEDICAL 4700 NA

    Patients

    Seq Age Sex Outcome Treatment
    1