BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    NARA, DOMESTIC

    MDR report key: 10743654 · Received October 27, 2020

    Report

    Report Number
    0001831750-2020-01130
    Event Type
    Malfunction
    Date Received
    October 27, 2020
    Date of Event
    July 1, 2020
    Report Date
    October 27, 2020
    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 · 1

    THIS MDR IS PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. 3 DEVICES WERE EVALUATED IN THE FIELD AND THE ISSUES WERE CONFIRMED; 2 DEVICES HAD BROKEN/DAMAGED COMPONENTS AND 1 DEVICE HAD BENT/DEFORMED COMPONENTS. THE DEVICES WERE REPAIRED AND RETURNED. THERE WAS NO REMEDIAL ACTION TAKEN. THESE DEVICES ARE NOT LABELED FOR SINGLE USE.

    Description of Event or Problem · 1

    THIS REPORT SUMMARIZES 3 MALFUNCTION EVENTS, WHERE IT WAS REPORTED THERE WERE ACCESSIBLE SHARP METAL EDGES. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1208071 NARA, DOMESTIC BASSINET, HOSPITAL NZG STRYKER MEDICAL-KALAMAZOO 4402 07613327261615

    Patients

    Seq Age Sex Outcome Treatment
    1