BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    NARA, DOMESTIC

    MDR report key: 23391969 · Received October 27, 2025

    Report

    Report Number
    0001831750-2025-99343
    Event Type
    Malfunction
    Date Received
    October 27, 2025
    Report Date
    October 27, 2025
    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. 2 DEVICE(S) WAS FUNCTIONALLY/VISUALLY INSPECTED IN THE FIELD. THE DEVICE(S) WAS/WERE REPAIRED AND RETURNED TO USE. 1 DEVICE WAS NOT EVALUATED, AS A PROBABLE CAUSE FOR THE ISSUE WAS IDENTIFIED DURING COMMUNICATION BETWEEN THE CUSTOMER AND STRYKER AND NO FURTHER ASSISTANCE WAS REQUESTED BY THE CUSTOMER. EVALUATION RESULTS FINDINGS (COMPONENTS/RESULTS). 1 DEVICE: CHASSIS/FRAME / FRACTURE PROBLEM. 2 DEVICES: WELD / FRACTURE PROBLEM. THERE WAS NO REMEDIAL ACTION TAKEN. THIS DEVICE IS NOT LABELED FOR SINGLE USE.

    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 3 MALFUNCTION EVENT(S), WHERE IT WAS REPORTED THE DEVICE EXPERIENCED ACCESSIBLE SHARP EDGES EXPOSED (METAL). NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2351592 NARA, DOMESTIC BASSINET, HOSPITAL NZG STRYKER MEDICAL-KALAMAZOO 07613327261615

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown