BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARESTREAM DRX-1 SYSTEM

    MDR report key: 2607558 · Received June 4, 2012

    Report

    Report Number
    1317307-2012-00003
    Event Type
    Malfunction
    Date Received
    June 4, 2012
    Date of Event
    March 17, 2012
    Report Date
    June 4, 2012
    Manufacturer
    CARESTREAM HEALTH, INC.
    Product Code
    MQB
    PMA / PMN Number
    K090318
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE BATTERY MANUFACTURE DATE IS 01/2012. THE BATTERY WAS NOT INSTALLED IN THE MEDICAL DEVICE (THE CARESTREAM DRX-1 SYSTEM) WHEN THE INCIDENT OCCURRED. THE SITE CONTACT DID NOT KNOW WHICH DRX-1 SYSTEM THE BATTERY HAD LAST BEEN USED INT. THE CARESTREAM DRX-1 SYSTEM WAS NOT RETURNED TO THE MANUFACTURER. THE BATTERY WAS RETURNED TO THE BATTERY MANUFACTURER FOR FAILURE ANALYSIS. A ROOT CAUSE HAS NOT YET BEEN IDENTIFIED. VARIOUS POSSIBLE CAUSES HAVE BEEN EVALUATED.

    Description of Event or Problem · 1

    THE CARESTREAM DRX-1 SYSTEM DETECTOR (FLAT PANEL DIGITAL IMAGER) USES A BATTERY. THE BATTERY WAS NOT INSTALLED IN THE DETECTOR WHEN THIS INCIDENT OCCURRED. THE BATTERY CHARGERS WERE MOUNTED ON THE WALL AND THE BATTERY WAS FOUND ON THE FLOOR, APPROXIMATELY 10 FEET FROM THE CHARGERS. THE BATTERY BECAME HOT ENOUGH TO MELT SOME OF THE PLASTIC CASING AND THE LABEL ON THE BATTERY CELL. THERE WERE NO KNOWN WITNESSES TO WHAT HAPPENED TO THE BATTERY. THE BATTERY WAS FOUND ON THE FLOOR, JUST BEFORE 5PM ON SATURDAY, AFTER A BURNING SMELL WAS NOTICED BY PERSONNEL IN THE VICINITY. IT IS NOT KNOWN WHEN OR IF THE BATTERY WAS PLACED INTO THE CHARGER. THE BATTERY CHARGER FROM THE SITE WAS ANALYZED AND NO RESIDUE WAS FOUND ON THE CHARGER. INVESTIGATION SHOWED THAT WHATEVER HAPPENED TO THE BATTERY OCCURRED OUTSIDE OF THE CHARGER. ONE CELL (#2 CELL) OF THIS BATTERY (THERE ARE 4 CELLS WITHIN EACH BATTERY) OVERHEATED AND PARTIALLY MELTED THE PLASTIC CASING OF THE BATTERY. A SMALL AREA ON THE FLOOR WAS BLACKENED - DUE TO INTERNAL THERMAL VENTING OF THE BATTERY PACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARESTREAM DRX-1 SYSTEM FLAT PANEL DIGITAL IMAGER MQB CARESTREAM HEALTH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1