BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SECURE 3 MED/SURG BEDOBS 01/13

    MDR report key: 3243553 · Received July 23, 2013

    Report

    Report Number
    0001831750-2013-06630
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Date of Event
    June 27, 2013
    Report Date
    June 27, 2013
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUPPLEMENTAL SUBMITTED AS THE INVESTIGATION CONCLUDED THAT THE BED WAS ELEVATED AND WOULDN¿T LOWER DUE TO A DAMAGED FOOT END LIFT ASSEMBLY.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE FOOT END OF BED WAS ELEVATED AND WOULD NOT LOWER DUE TO DAMAGED LIFT MOTOR. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE FOOT END OF BED WAS ELEVATED AND WOULD NOT LOWER DUE TO DAMAGED FOOT END LIFT ASSEMBLY. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342602 SECURE 3 MED/SURG BEDOBS 01/13 BED, AC-POWERED ADJUSTABLE HOSPITAL FNL STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1