BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    ULTRA COMFORT, SE 4 X 30 W/FB

    MDR report key: 8836093 · Received July 29, 2019

    Report

    Report Number
    0001831750-2019-00839
    Event Type
    Malfunction
    Date Received
    July 29, 2019
    Date of Event
    April 1, 2019
    Report Date
    October 23, 2019
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    IKY
    UDI-DI
    07613327278248
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES WERE ORIGINALLY REPORTED TO BE CATALOG# 1115000000X, PRODUCT CODE FPO. HOWEVER, IT WAS DISCOVERED THE DEVICES ON THIS MDR SHOULD BE CATALOG# 1704034301, PRODUCT CODE IKY.

    Additional Manufacturer Narrative · 1

    THIS MDR IS A CONSOLIDATION OF RECORDS SUMMARIZED AS PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. THE DEVICES WERE EVALUATED IN THE FIELD BUT THE ISSUE WAS NOT CONFIRMED; NO DEFECTS OR MALFUNCTIONS WERE FOUND. THERE WAS NO REMEDIAL ACTION TAKEN. THIS DEVICE IS NOT LABELED FOR SINGLE USE.

    Description of Event or Problem · 1

    THIS REPORT SUMMARIZES <NOE> 10 </NOE> MALFUNCTION EVENTS, WHERE IT WAS REPORTED THE MATTRESS SLIPPED OFF THE LITTER. THERE WAS PATIENT INVOLVEMENT, HOWEVER THERE WERE NO CONSEQUENCES OR IMPACTS TO THE PATIENT.

    Description of Event or Problem · 1

    THIS REPORT SUMMARIZES <NOE> 10 </NOE> MALFUNCTION EVENTS, WHERE IT WAS REPORTED THE MATTRESS SLIPPED OFF THE LITTER. THERE WAS PATIENT INVOLVEMENT, HOWEVER THERE WERE NO CONSEQUENCES OR IMPACTS TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    628969 ULTRA COMFORT, SE 4 X 30 W/FB MATTRESS, FLOTATION THERAPY, NON-POWERED IKY STRYKER MEDICAL-KALAMAZOO 07613327278248

    Patients

    Seq Age Sex Outcome Treatment
    1