BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUB PEDIATRIC CRIB- FIXED BASE

    MDR report key: 3071250 · Received April 22, 2013

    Report

    Report Number
    0001831750-2013-03621
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Date of Event
    March 26, 2013
    Report Date
    March 26, 2013
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FMS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    A VISUAL AND FUNCTIONAL INSPECTION WAS PERFORMED BY THE REPAIR TECHNICIAN AND IT WAS FOUND THIS UNIT WAS NOT ASSEMBLED WITH THE OPTIONAL COMBINED STEER/BRAKE MECHANISM. THE BRAKES FOR THIS UNIT ARE LOCATED ON EACH CASTER. IT WAS REPORTED THAT THE DELIVERY PERSON WHO DELIVERED THIS UNIT THOUGHT THAT THIS UNIT HAD THE OPTIONAL COMBINED STEER/BRAKE MECHANISM INSTALLED. THERE WAS NO DEFECT FOUND WITH THIS UNIT AND THE UNIT PERFORMED TO SPECIFICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE UNIT WAS DELIVERED WITH NO FUNCTIONING BRAKES. STRYKER TECHNICIAN REPLACED THE BRAKES AND RETURNED THE UNIT TO SERVICE. 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 REPAIR WORK ORDER THAT THE UNIT WAS DELIVERED WITH NO FUNCTIONING BRAKES. STRYKER TECHNICIAN REPLACED THE BRAKES AND RETURNED THE UNIT TO SERVICE. 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
    172665 CUB PEDIATRIC CRIB- FIXED BASE BED, PEDIATRIC OPEN HOSPITAL FMS STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1