BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    NARA, DOMESTIC

    MDR report key: 19850109 · Received July 29, 2024

    Report

    Report Number
    0001831750-2024-01025
    Event Type
    Malfunction
    Date Received
    July 29, 2024
    Date of Event
    April 1, 2024
    Report Date
    August 20, 2024
    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. 3 DEVICES ARE PENDING EVALUATION. THERE WAS NO REMEDIAL ACTION TAKEN. THIS DEVICE IS NOT LABELED FOR SINGLE USE.

    Additional Manufacturer Narrative · 0

    FOR THE 3 DEVICES THAT WERE PENDING, IT WAS REPORTED THAT THE CUSTOMER WAS DISSATISFIED WITH THE NARA MATTRESS AS DESIGNED AND FELT IT WAS TOO SOFT. PER 21 CFR 820 THIS DOES NOT MEET THE DEFINITION OF A COMPLAINT AS THERE WAS NO MALFUNCTION OF A MEDICAL DEVICE, ADVERSE EVENT, OR PATIENT INVOLVEMENT. THEREFORE, NO REGULATORY REPORTING IS REQUIRED. SECTION H CODES HAVE BEEN UPDATED.

    Description of Event or Problem · 0

    THIS REPORT SUMMARIZES 3 MALFUNCTION EVENTS, WHERE IT WAS REPORTED THE DEVICES EXPERIENCED MATTRESS IS TOO SOFT; TOO MUCH MATTRESS IMMERSION. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    THIS REPORT SUMMARIZES 0 MALFUNCTION EVENTS, WHERE IT WAS REPORTED THE DEVICES EXPERIENCED MATTRESS IS TOO SOFT; TOO MUCH MATTRESS IMMERSION. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1036773 NARA, DOMESTIC BASSINET, HOSPITAL NZG STRYKER MEDICAL-KALAMAZOO 07613327261615

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown