BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    INTOUCH ZOOM MTS PREV PCK

    MDR report key: 12693787 · Received October 25, 2021

    Report

    Report Number
    0001831750-2021-01430
    Event Type
    Malfunction
    Date Received
    October 25, 2021
    Date of Event
    July 1, 2021
    Report Date
    December 6, 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
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    UPON FURTHER INVESTIGATION OF 1 OF THE DEVICES, IT WAS DETERMINED THAT IT WAS ONLY EXPERIENCING COSMETIC DAMAGE, WHICH IS NOT REPORTABLE. THE COUNT OF EVENTS HAS BEEN CORRECTED TO REFLECT THIS.

    Description of Event or Problem · 0

    THIS REPORT SUMMARIZES 1 MALFUNCTION EVENTS, WHERE IT WAS REPORTED THE DEVICE EXPERIENCED ZOOM RETRACTS/DISENGAGES DURING USE. THERE WAS NO PATIENT INVOLVEMENT.

    Additional Manufacturer Narrative · 1

    THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. 2 DEVICES WERE FUNCTIONALLY/VISUALLY INSPECTED IN THE FIELD. THE DEVICES WERE REPAIRED AND RETURNED TO USE. THERE WAS NO REMEDIAL ACTION TAKEN. THIS DEVICE IS NOT LABELED FOR SINGLE USE.

    Description of Event or Problem · 1

    THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS, WHERE IT WAS REPORTED THE DEVICES EXPERIENCED THE ZOOM SUDDENLY STOPS OR THE ZOOM RETRACTS/DISENGAGES DURING USE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1586627 INTOUCH ZOOM MTS PREV PCK BED, AC-POWERED ADJUSTABLE HOSPITAL FNL STRYKER MEDICAL-KALAMAZOO 2141 07613327385427

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown