BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTOUCH ZU

    MDR report key: 2581943 · Received May 2, 2012

    Report

    Report Number
    1831750-2012-04779
    Event Type
    Malfunction
    Date Received
    May 2, 2012
    Date of Event
    April 4, 2012
    Report Date
    April 4, 2012
    Manufacturer
    FLEXTRONICS EMS CANADA
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: BRAKE LEVER.

    Description of Event or Problem · 1

    IT WAS REPORTED BY SERVICE REPORT THAT THE BRAKES WERE NOT HOLDING. THERE WAS PT INVOLVEMENT AND A CAREGIVER WAS ALLEGEDLY INJURED, HOWEVER NO INJURIES OR ADVERSE CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTOUCH ZU A/C HOSPITAL BED FNL FLEXTRONICS EMS CANADA 2141 NA

    Patients

    Seq Age Sex Outcome Treatment
    1