BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    INTOUCH ZOOM MTS PREV PCK

    MDR report key: 19837517 · Received July 26, 2024

    Report

    Report Number
    0001831750-2024-00906
    Event Type
    Malfunction
    Date Received
    July 26, 2024
    Date of Event
    April 1, 2024
    Report Date
    July 26, 2024
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FNL
    UDI-DI
    07613327385427
    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 NOT EVALUATED AND NO CAUSE WAS DETERMINED, AS THE CUSTOMER DID NOT MAKE THE DEVICE ACCESSIBLE FOR TESTING. 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 UNINTENDED DIRECTION OF THE ZOOM. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    459454 INTOUCH ZOOM MTS PREV PCK BED, AC-POWERED ADJUSTABLE HOSPITAL FNL STRYKER MEDICAL-KALAMAZOO 07613327385427

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown