BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUB PEDIATRIC CRIB- HYD BASE

    MDR report key: 3022567 · Received March 27, 2013

    Report

    Report Number
    0001831750-2013-02562
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Date of Event
    February 27, 2013
    Report Date
    February 27, 2013
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FMS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE MANUFACTURER'S INVESTIGATION IT WAS DETERMINED THAT THE TOP RAILS HAVE GAPS BETWEEN THE SEAMS, BUT THIS WOULD NOT HAVE PREVENTED THE SIDE RAIL FROM LATCHING OR BECOMING UNLATCHED DURING USE. THE ISSUE WAS RESOLVED FOR THE CUSTOMER BY REPLACING THE UNIT.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA EMAIL THAT THE DOOR ON THE CUB COULD OPEN UNINTENTIONALLY DURING USE. MANUFACTURER'S INVESTIGATION IS STILL ONGOING. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT MAY BE SUBMITTED. 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 EMAIL THAT THE DOOR ON THE CUB COULD OPEN UNINTENTIONALLY DURING USE. MANUFACTURER'S INVESTIGATION IS STILL ONGOING. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT MAY BE SUBMITTED. 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
    125012 CUB PEDIATRIC CRIB- HYD BASE BED, PEDIATRIC OPEN HOSPITAL FMS STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1