BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRETCHER CHAIR

    MDR report key: 3080946 · Received April 26, 2013

    Report

    Report Number
    0001831750-2013-03774
    Event Type
    Malfunction
    Date Received
    April 26, 2013
    Date of Event
    April 2, 2013
    Report Date
    April 2, 2013
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FPO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER WILL REPAIR DEVICES THEMSELVES. CUSTOMER EVALUATED.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE ARM PADS WERE PUNCTURED WITH ALLEGED FLUID INGRESS. 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
    183152 STRETCHER CHAIR STRETCHER, WHEELED FPO STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1