BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IN TOUCH ZX

    MDR report key: 2964288 · Received February 15, 2013

    Report

    Report Number
    0001831750-2013-01242
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    January 23, 2013
    Report Date
    January 23, 2013
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - POWER CONTROL BOARD.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP SUMBIITED AS FURTHER INVESTIGATION DETERMINED THE BED HAD LOST MOTOR CONTROLS DUE TO A CPU BOARD AND BASE ANGLE SENSOR MALFUNCTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BED HAD NO POWER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BED HAD LOST MOTOR CONTROLS DUE TO A CPU BOARD AND BASE ANGLE 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
    67408 IN TOUCH ZX BED, AC-POWERED ADJUSTABLE HOSPITAL FNL STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1