BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EZ-PRO R4 AMBUL COT OBS(5/08)

    MDR report key: 3150454 · Received June 6, 2013

    Report

    Report Number
    0001831750-2013-05142
    Event Type
    Malfunction
    Date Received
    June 6, 2013
    Date of Event
    May 10, 2013
    Report Date
    May 10, 2013
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FPO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ISSUE WAS RESOLVED FOR THE CUSTOMER BY INSTRUCTING THE CUSTOMER HOW TO PROPERLY ADJUST THE HEIGHT ON THE COT.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE HEIGHT ADJUSTMENT WAS STUCK AND THE COT COULD NOT BE LOWERED. 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 HEIGHT ADJUSTMENT WAS STUCK AND THE COT COULD NOT BE LOWERED. 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
    251800 EZ-PRO R4 AMBUL COT OBS(5/08) STRETCHER, WHEELED FPO STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1