BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IN TOUCH ZU

    MDR report key: 2873653 · Received November 14, 2012

    Report

    Report Number
    1831750-2012-11792
    Event Type
    Malfunction
    Date Received
    November 14, 2012
    Date of Event
    October 16, 2012
    Report Date
    October 16, 2012
    Manufacturer
    FLEXTRONICS EMS CANADA
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): POWER INLET.

    Description of Event or Problem · 1

    IT WAS REPORTED BY SERVICE REPORT THAT THE POWER INLET WAS CRACKED WITH A POTENTIAL FOR EXPOSED ELECTRICAL WIRES. THE CUSTOMER REPORTED THAT THEY DID NOT KNOW IF THERE WAS PATIENT INVOLVEMENT; HOWEVER, NO ADVERSE CONSEQUENCES WERE REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1