BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    INTOUCH ZOOM MTS PREV PCK

    MDR report key: 11711265 · Received April 22, 2021

    Report

    Report Number
    0001831750-2021-00779
    Event Type
    Malfunction
    Date Received
    April 22, 2021
    Date of Event
    January 1, 2021
    Report Date
    April 22, 2021
    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 · 1

    THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. 1 DEVICE WAS FUNCTIONALLY/VISUALLY INSPECTED IN THE FIELD. THE DEVICE WAS REPAIRED AND RETURNED TO USE. 1 DEVICE WAS EVALUATED IN THE FIELD AND THE ISSUE WAS CONFIRMED.  HOWEVER, THERE WAS NO PRODUCT MALFUNCTION; THE ISSUE WAS THE RESULT OF USE ERROR AS THE SCALE WAS NOT PROPERLY ZEROED BEFORE USE. THERE WAS NO REMEDIAL ACTION TAKEN. THESE DEVICES ARE NOT LABELED FOR SINGLE USE.

    Description of Event or Problem · 1

    THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS, WHERE IT WAS REPORTED THAT THE SCALE IS INACCURATE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602898 INTOUCH ZOOM MTS PREV PCK BED, AC-POWERED ADJUSTABLE HOSPITAL FNL STRYKER MEDICAL-KALAMAZOO 2141 07613327385427

    Patients

    Seq Age Sex Outcome Treatment
    1