BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOOM CRITICAL CARE BED

    MDR report key: 2990637 · Received March 5, 2013

    Report

    Report Number
    0001831750-2013-01758
    Event Type
    Malfunction
    Date Received
    March 5, 2013
    Date of Event
    January 28, 2013
    Report Date
    February 7, 2013
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE FOWLER WAS NOT FUNCTIONING DUE TO A BROKEN BALL SCREW 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
    94019 ZOOM CRITICAL CARE BED BED, AC-POWERED ADJUSTABLE HOSPITAL FNL STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1