BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IN TOUCH ZU

    MDR report key: 2883830 · Received November 15, 2012

    Report

    Report Number
    1831750-2012-11978
    Event Type
    Malfunction
    Date Received
    November 15, 2012
    Date of Event
    October 19, 2012
    Report Date
    October 19, 2012
    Manufacturer
    STRYKER MEDICAL
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULT: SHARP EDGES ON ZOOM HANDLE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY SERVICE REPORT THAT THE ZOOM HANDLE WAS CRACKED, EXPOSING SHARP EDGES. NO PT INVOLVEMENT OR ADVERSE CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IN TOUCH ZU A/C HOSPITAL BED FNL STRYKER MEDICAL 2141 NA

    Patients

    Seq Age Sex Outcome Treatment
    1