BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUB PEDIATRIC CRIB- HYD BASE

    MDR report key: 3762131 · Received April 21, 2014

    Report

    Report Number
    0001831750-2014-02926
    Event Type
    Malfunction
    Date Received
    April 21, 2014
    Date of Event
    March 20, 2014
    Report Date
    March 28, 2014
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FZM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED TO THE STRYKER SALES REPRESENTATIVE, THAT AN ALLEGED EVENT OCCURRED WHEN A PATIENT WAS REACHING FOR AN OBJECT OUTSIDE OF THE CUB CRIB. WHILE REACHING THROUGH THE RAILS, THE PATIENTS ARM BECAME STUCK AT THE ELBOW. IT WAS REPORTED THAT A NURSE WAS ABLE TO GET THE ARM UNSTUCK AND THE PATIENT RECEIVED A BRUISE FROM THE ALLEGED EVENT. A STRYKER QUALITY ASSURANCE ENGINEER CONTACTED THE CUSTOMER FOR ADDITIONAL INFORMATION ABOUT THE REPORTED EVENT. THE CUSTOMER REPORTED THAT THERE WAS NO MALFUNCTION/DEFECT WITH THE STRETCHER, AND THAT THEY DID NOT NEED THE UNIT OR OTHER CUB CRIB UNITS EVALUATED. THE CUSTOMER ALSO REPORTED THAT THE PATIENT ONLY HAD MINOR BRUISING WITH NO MEDICAL INTERVENTION REQUIRED. THE UNIT WAS RETURNED INTO SERVICE AND A SERIAL NUMBER COULD NOT BE DETERMINED. NO MALFUNCTION/DEFECT ALLEGED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD THEIR LEFT ELBOW STUCK BETWEEN THE BARS OF THE CRIB RAIL. THE PATIENTS ELBOW WAS REMOVED FROM THE CRIB RAIL AND BRUISING TO THE LEFT ELBOW WAS OBSERVED. THERE WAS PATIENT INVOLVEMENT; HOWEVER, NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD THEIR LEFT ELBOW STUCK BETWEEN THE BARS OF THE CRIB RAIL. THE PATIENTS ELBOW WAS REMOVED FROM THE CRIB RAIL AND BRUISING TO THE LEFT ELBOW WAS OBSERVED. THERE WAS PATIENT INVOLVEMENT; HOWEVER, NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    239260 CUB PEDIATRIC CRIB- HYD BASE PEDIATRIC OPEN HOSPITAL BED FZM STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1