BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 3041763 · Received April 8, 2013

    Report

    Report Number
    0001831750-2013-03032
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    March 11, 2013
    Report Date
    March 11, 2013
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FPO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS IDENTIFIED DURING THE INVESTIGATION THAT THE COT DROP ISSUE REPORTED WAS DUE TO USER ERROR. THE UNIT DID NOT HAVE A MECHANICAL ISSUE THAT CAUSED THIS EVENT. THE USER FACILITY REPORTED THAT THEY ARE HANDLING THIS USER ERROR EVENT INTERNALLY.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE COT MAY HAVE ISSUES WITH DROPPING WHEN PATIENT WEIGHT IS APPLIED. 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 COT MAY HAVE ISSUES WITH DROPPING WHEN PATIENT WEIGHT IS APPLIED. 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
    142735 EZ-PRO R4 AMBUL COT OBS(5/08) STRETCHER, WHEELED FPO STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1