BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    CUB

    MDR report key: 10005193 · Received April 28, 2020

    Report

    Report Number
    0001831750-2020-00562
    Event Type
    Malfunction
    Date Received
    April 28, 2020
    Date of Event
    January 1, 2020
    Report Date
    July 14, 2020
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FMS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT EVALUATED AND NO CAUSE WAS DETERMINED, AS THE CUSTOMER DID NOT MAKE THE DEVICE ACCESSIBLE FOR TESTING. H3 OTHER TEXT : SEE H11.

    Description of Event or Problem · 0

    THIS REPORT SUMMARIZES <NOE> 1 </NOE> MALFUNCTION EVENT, WHERE IT WAS REPORTED THE SIDERAIL HAD A FALSE LATCH.  THERE WAS NO PATIENT INVOLVEMENT.

    Additional Manufacturer Narrative · 1

    THIS MDR IS A CONSOLIDATION OF RECORDS SUMMARIZED AS PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. THE DEVICE IS PENDING EVALUATION. THERE WAS NO REMEDIAL ACTION TAKEN. THIS DEVICE IS NOT LABELED FOR SINGLE USE.

    Description of Event or Problem · 1

    THIS REPORT SUMMARIZES <NOE> 1 </NOE> MALFUNCTION EVENT, WHERE IT WAS REPORTED THE SIDERAIL HAD A FALSE LATCH.  THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470181 CUB BED, PEDIATRIC OPEN HOSPITAL FMS STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1