BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    NARA, DOMESTIC

    MDR report key: 23391970 · Received October 27, 2025

    Report

    Report Number
    0001831750-2025-99340
    Event Type
    Malfunction
    Date Received
    October 27, 2025
    Report Date
    January 7, 2026
    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. 1 DEVICE IS PENDING EVALUATION. EVALUATION RESULTS FINDINGS (COMPONENTS/RESULTS). 1 DEVICE: APPROPRIATE TERM/CODE NOT AVAILABLE / RESULTS PENDING COMPLETION OF INVESTIGATION THERE WAS NO REMEDIAL ACTION TAKEN. THIS DEVICE IS NOT LABELED FOR SINGLE USE.

    Additional Manufacturer Narrative · 0

    THE DEVICE THAT WAS PENDING EVALUATION WAS NOT MADE AVAILABLE BY THE CUSTOMER; THE REPORTED ISSUE WAS NOT CONFIRMED. EVALUATION RESULTS FINDINGS (COMPONENTS/RESULTS). 1 DEVICE: PAD/NO FINDINGS AVAILABLE.

    Description of Event or Problem · 0

    THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN JULY 1-SEPTEMBER 30, 2025. THIS REPORT SUMMARIZES 1 MALFUNCTION EVENTS(S), WHERE IT WAS REPORTED THE DEVICES EXPERIENCED MATTRESS IS TOO SOFT; TOO MUCH MATTRESS IMMERSION. NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

    Description of Event or Problem · 0

    NO NEW INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40617 NARA, DOMESTIC BASSINET, HOSPITAL NZG STRYKER MEDICAL-KALAMAZOO 07613327261615

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown