BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    NARA, DOMESTIC

    MDR report key: 14194751 · Received April 25, 2022

    Report

    Report Number
    0001831750-2022-00335
    Event Type
    Malfunction
    Date Received
    April 25, 2022
    Date of Event
    January 1, 2022
    Report Date
    April 25, 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

    Narratives

    Additional Manufacturer Narrative · 0

    THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. 1 DEVICE WAS FUNCTIONALLY/VISUALLY INSPECTED IN THE FIELD. THE DEVICE WAS REPAIRED AND RETURNED TO USE. THERE WAS NO REMEDIAL ACTION TAKEN. THIS DEVICE IS NOT LABELED FOR SINGLE USE.

    Description of Event or Problem · 0

    THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT, WHERE IT WAS REPORTED THE DEVICE EXPERIENCED THE BASSINET TUB WAS STRUCTURALLY COMPROMISED LEADING TO A BREAK. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    198137 NARA, DOMESTIC BASSINET, HOSPITAL NZG STRYKER MEDICAL-KALAMAZOO 4402 07613327261615

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown