BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IN TOUCH EU

    MDR report key: 3182643 · Received June 21, 2013

    Report

    Report Number
    0001831750-2013-05675
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    May 24, 2013
    Report Date
    May 29, 2013
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUPPLEMENTAL SUBMITTED AS INVESTIGATION FOUND THERE WAS A FAULTY MAIN CABLE HARNESS #2, WHICH ALSO CONTRIBUTED TO THE ISSUE OF THE LIFTS NOT LOWERING, IN ADDITION TO THE MALFUNCTIONED TILT SENSORS.

    Description of Event or Problem · 1

    IT WAS REPORTED BY REPAIR WORK ORDER THAT THE LIFT WOULD NOT LOWER TO ITS LOWEST HEIGHT DUE TO TILT SENSOR MALFUNCTION AND A FAULTY MAIN CABLE HARNESS #2. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY REPAIR WORK ORDER THAT THE LIFT WOULD NOT LOWER TO ITS LOWEST HEIGHT DUE TO TILT SENSOR MALFUNCTION. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    284019 IN TOUCH EU BED, AC-POWERED ADJUSTABLE HOSPITAL FNL STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1