BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RENAISSANCE 29 P-WASH

    MDR report key: 2140673 · Received June 15, 2011

    Report

    Report Number
    1831750-2011-05997
    Event Type
    Malfunction
    Date Received
    June 15, 2011
    Date of Event
    May 18, 2011
    Report Date
    May 18, 2011
    Manufacturer
    STRYKER MEDICAL
    Product Code
    FPO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY SERVICE REPORT THAT THE COVER AROUND THE ZOOM HANDLES WAS CRACKED AND DAMAGED WITH SHARP EDGES. NO PATIENT INVOLVEMENT OR ADVERSE CONSEQUENCES ARE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RENAISSANCE 29 P-WASH HOSPITAL WHEELED STRETCHER FPO STRYKER MEDICAL 1731 NA

    Patients

    Seq Age Sex Outcome Treatment
    1