BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOS

    MDR report key: 3873855 · Received May 19, 2014

    Report

    Report Number
    3873855
    Event Type
    Malfunction
    Date Received
    May 19, 2014
    Date of Event
    May 7, 2014
    Report Date
    May 19, 2014
    Manufacturer
    KLS MARTIN , LP
    Product Code
    MOQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    AFTER THE PATIENT HAD LEFT THE ROOM THE TRASH WAS NOTED TO BE SMOKING AND QUICKLY CAUGHT FIRE. THERE WERE TWO NURSES IN THE OPERATING ROOM AT THE TIME. THEY FIRST DUMPED FLUIDS ON THE FIRE BUT IT WAS NOT EXTINGUISHED. THE FIRE ALARM WAS PULLED, THEN THE FIRE WAS EXTINGUISHED USING A FIRE EXTINGUISHER. THE FIRE DEPARTMENT RESPONDED AND VERIFIED THE FIRE WAS COMPLETELY OUT. THE SOURCE OF IGNITION APPEARS TO BE A DISCARDED BATTERY PACK FROM THE DRILL. THE CONTACTS OF THE BATTERY APPARENTLY SHORTED OUT ON PIECES OF ALUMINUM FOIL OR WIRE THAT WERE IN THE TRASH BAG, OVERHEATED, AND CAUGHT ON FIRE. NUMEROUS FOIL PACKAGES FROM SUTURES AND SCALPEL BLADES WERE OBSERVED IN THE TRASH AND THEY ARE HIGHLY CONDUCTIVE ON THE SURFACE.DIRECTIONS FOR USE THAT COME WITH THE BATTERY INCLUDE A WARNING AGAINST SHORTING THE TERMINALS AND TO DISPOSE OF THE BATTERY PROPERLY. THE TERMINALS ON THE BATTERY PROTRUDE FROM THE CASE AND ARE RELATIVELY EASY TO SHORT OUT. RECESSED TERMINALS WOULD BE LESS LIKELY TO SHORT. THERE WAS NO PATIENT INVOLVEMENT AS THE PATIENT HAD ALREADY LEFT THE ROOM AND THE DAMAGE WAS CONFINED TO THE TRASH BAG.======================MANUFACTURER RESPONSE FOR BATTERY PACK, KLS MARTIN (PER SITE REPORTER).======================AWAITING EVALUATION OF DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295839 BOS DRILL MOQ KLS MARTIN , LP * 32616592

    Patients

    Seq Age Sex Outcome Treatment
    1 * VARIOUS DISPOSABLE ITEMS SUCH AS SUTURES AND| SCALPEL BLADES.