BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    NARA, DOMESTIC

    MDR report key: 14209250 · Received April 26, 2022

    Report

    Report Number
    0001831750-2022-00511
    Event Type
    Malfunction
    Date Received
    April 26, 2022
    Date of Event
    January 1, 2022
    Report Date
    June 27, 2022
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    NZG
    UDI-DI
    07613327261615
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. 4 DEVICES WERE FUNCTIONALLY/VISUALLY INSPECTED IN THE FIELD. THE DEVICES WERE REPAIRED AND RETURNED TO USE. 3 DEVICES ARE PENDING EVALUATION. THERE WAS NO REMEDIAL ACTION TAKEN. THIS DEVICE IS NOT LABELED FOR SINGLE USE.

    Additional Manufacturer Narrative · 0

    UPON INVESTIGATION OF THE 3 DEVICES THAT WERE PENDING EVALUATION, THE USER FACILITY STATED THAT THOSE DEVICES WERE NOT EXPERIENCING ANY ISSUES AND IT WAS MISREPORTED. THE COUNT OF EVENTS HAS BEEN UPDATED TO REFLECT THIS.

    Description of Event or Problem · 0

    THIS REPORT SUMMARIZES 7 MALFUNCTION EVENTS, WHERE IT WAS REPORTED THE DEVICES EXPERIENCED THE BASKET FALLS FROM A TILT POSITION OR CANNOT BE TILTED. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    THIS REPORT SUMMARIZES 4 MALFUNCTION EVENTS, WHERE IT WAS REPORTED THE DEVICES EXPERIENCED THE BASKET FALLS FROM A TILT POSITION OR CANNOT BE TILTED. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1026216 NARA, DOMESTIC BASSINET, HOSPITAL NZG STRYKER MEDICAL-KALAMAZOO 4402 07613327261615

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown