BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUB PEDIATRIC CRIB- HYD BASE

    MDR report key: 3954639 · Received July 24, 2014

    Report

    Report Number
    0001831750-2014-03173
    Event Type
    Malfunction
    Date Received
    July 24, 2014
    Date of Event
    July 11, 2014
    Report Date
    July 11, 2014
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FMS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS CONFIRMED THAT THE UNIT WAS BUILT CORRECTLY DURING MANUFACTURING. THE SIDERAILS ON THIS UNIT ARE AVAILABLE IN TWO DIFFERENT STYLES. ONE STYLE WHERE THE SIDERAIL RAISES AND LOWERS COMPLETELY WHEN UNLATCHED. THE OTHER STYLES HAS AN INTERMEDIATE STOP SO THE RAIL CANNOT BE RAISED OR LOWERED IN ONE FULL MOTION. THIS UNIT HAS THE INTERMEDIATE STOP STYLE SIDERAILS. THE CUSTOMER DID NOT LIKE THIS STYLE AND REQUESTED THAT THE OTHER STYLE BE INSTALLED. NO MALFUNCTIONS WERE REPORTED AND THE UNIT WAS CONFIRMED TO BE ASSEMBLED TO SPECIFICATION. THIS IS A CUSTOMER PREFERENCE ISSUE ONLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SIDERAILS MAY NOT LATCH DUE TO HAVING THE INCORRECT CENTER LATCH ASSEMBLY INSTALLED. 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 THAT THE SIDERAILS MAY NOT LATCH DUE TO HAVING THE INCORRECT CENTER LATCH ASSEMBLY INSTALLED. 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
    433721 CUB PEDIATRIC CRIB- HYD BASE BED, PEDIATRIC OPEN HOSPITAL FMS STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1