BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SECURE II MED/SURG BED

    MDR report key: 2140775 · Received May 31, 2011

    Report

    Report Number
    1831750-2011-05246
    Event Type
    Malfunction
    Date Received
    May 31, 2011
    Date of Event
    May 3, 2011
    Report Date
    May 3, 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: CRACKED HEAD LEFT SIDERAIL PANEL WITH FLUID INGRESS. CRACKED PLASTIC SCALE MODULE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY SERVICE REPORT THAT THE HEAD LEFT SIDE RAIL PANEL WAS CRACKED, AND THERE WAS FLUID INTRUSION. THE SCALE MODULE WAS ALSO CRACKED. NO PATIENT INVOLVEMENT OR ADVERSE CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SECURE II MED/SURG BED A/C POWERED HOSPITAL BED FNL STRYKER MEDICAL 3002 EX NA

    Patients

    Seq Age Sex Outcome Treatment
    1