BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARESTREAM DRX-REVOLUTION MOBILE X-RAY SYSTEM

    MDR report key: 3960792 · Received June 10, 2014

    Report

    Report Number
    1317307-2014-00005
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    May 11, 2014
    Report Date
    June 10, 2014
    Manufacturer
    CARESTREAM HEALTH
    Product Code
    IZL
    PMA / PMN Number
    K120062
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ROOT CAUSE OF THE ISSUE WAS ASSESSED TO BE AN INTERNAL SHORT IN THE BATTERY. THE ISSUE WAS RESOLVED BY REPLACING THE BATTERY PACK.

    Description of Event or Problem · 1

    CARESTREAM FIELD ENGINEER REPLACED THE BATTERY PACK AND FOUND BLACK RESIDUE IN THE COMPARTMENT. HE ALSO FOUND THAT ONE OF THE BATTERIES IN THE PACK HAD CRACKED. CUSTOMER WAS UNAWARE OF THE INCIDENT. HE ALSO NOTED A SMALL BURN HOLE IN THE CASE. THE ISSUE DID NOT RESULT IN AN INJURY TO ANY PERSON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    337034 CARESTREAM DRX-REVOLUTION MOBILE X-RAY SYSTEM DRX-REVOLUTION IZL CARESTREAM HEALTH

    Patients

    Seq Age Sex Outcome Treatment
    1 NA