BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUB PEDIATRIC CRIB

    MDR report key: 2862000 · Received October 31, 2012

    Report

    Report Number
    1831750-2012-11358
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Date of Event
    October 1, 2012
    Report Date
    October 1, 2012
    Manufacturer
    STRYKER MEDICAL
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER HAS EVALUATED THE DEVICE AND WILL COMPLETE THE REPAIRS. CENTRAL LOCKING COLUMN. MANUFACTURER'S INVESTIGATION IS STILL ONGOING. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT MAY BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY SERVICE REPORT THAT THE SIDE RAIL COULD NOT REMAIN LATCHED. IT IS NOT KNOWN WHETHER THERE WAS PATIENT INVOLVEMENT OR ADVERSE CONSEQUENCES TO REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CUB PEDIATRIC CRIB PEDIATRIC HOSPITAL BED FNL STRYKER MEDICAL FL19F NA

    Patients

    Seq Age Sex Outcome Treatment
    1