BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SM104 M-SERIES W/5TH WHEEL

    MDR report key: 2072130 · Received April 21, 2011

    Report

    Report Number
    1831750-2011-03878
    Event Type
    Malfunction
    Date Received
    April 21, 2011
    Date of Event
    March 24, 2011
    Report Date
    March 24, 2011
    Manufacturer
    STRYKER MEDICAL
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULT: FOWLER STUCK IN THE UPPER POSITION.

    Description of Event or Problem · 1

    IT WAS REPORTED BY SERVICE REPORT THAT THE GAS CYLINDER THAT OPERATES THE FOWLER IS LEAKING ONTO THE BASE HOOD, AND IT WOULD NOT LOWER OR RISE. THE 5TH WHEEL ASSEMBLY WAS DAMAGED, AND WOULD NOT ENGAGE. IT IS UNK IF THERE WAS PT INVOLVEMENT OR ADVERSE CONSEQUENCES TO REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SM104 M-SERIES W/5TH WHEEL A/C POWERED HOSPITAL BED FNL STRYKER MEDICAL 1007 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA