BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IN TOUCH ZX

    MDR report key: 3241296 · Received July 22, 2013

    Report

    Report Number
    0001831750-2013-06560
    Event Type
    Malfunction
    Date Received
    July 22, 2013
    Date of Event
    June 24, 2013
    Report Date
    June 25, 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

    FOLLOW-UP SUBMITTED AS IT WAS ALLEGED THAT THE LIFT WAS STUCK IN HIGH HEIGHT. HOWEVER, THE UNIT WAS EVALUATED BY THE SERVICE TECHNICIAN AND THE REPORTED EVENT COULD NOT BE DUPLICATED. THERE WAS NO MALFUNCTION AND NO CORRECTION WAS REQUIRED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY REPAIR WORK ORDER THAT THE BED WAS STUCK AT AN ELEVATED HEIGHT. 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 BED WAS STUCK AT AN ELEVATED HEIGHT. 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
    341789 IN TOUCH ZX BED, AC-POWERED ADJUSTABLE HOSPITAL FNL STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1