BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSLASH KIT

    MDR report key: 26212 · Received September 28, 1995

    Report

    Report Number
    MW1007136
    Event Type
    Malfunction
    Date Received
    September 28, 1995
    Date of Event
    May 20, 1995
    Report Date
    September 21, 1995
    Manufacturer
    O.R. SOLUTIONS, INC.
    Product Code
    KDD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    DURING A PRE-USE EVALUATION ON 5/23/95, RPTR FOUND THAT DEVICE DID NOT PASS REQUIREMENTS FOR USE; NO UL APPROVAL & THERE WAS ELECTRICAL LEAKAGE. THE KIT MFR CLAIMED THAT DEVICE HAD ELECTRICAL APPROVAL FROM THE CITY'S STANDARDS SETTING BODY, BUT WHEN RPTR CONTACTED THEM, THIS WAS FOUND TO BE FALSE. THE KIT WAS USED TO MODIFY OTHER DEVICES USED IN THE OR. ACCORDING TO RPTR THE KIT IS MFG USING CHEAP COMPONENTS. THE STAINLESS STEEL LOGO PLATE WAS VERY SHARP, CUTTING RPTR NECESSITATING A TETANUS SHOT, HEPATITIS VACCINE & THE DRAWING OF HIV BASELING. IN ADDITION, THE MOTOR-LIFTING MECHANISM HAS AN AWKWARD DESIGN & THE WHEELS ARE UNSTABLE/NOT ALL MAKING CONTACT WITH THE FLOOR, CAUSING DEVICE TO TILT. THE OR STAFF WAS ADVISED OF ELECTRICAL HAZARD. TWO WEEKS LATER, A FREEZING BATH, MODIFIED USING ONE OF THESE KITS, FAILED DURING OPEN HEART SURGERY, CAUSING LIM (LINE ISOLATION MONITOR) ALARMS TO SOUND. THESE MONITOR ELECTRICAL OUTLETS & ALERT STAFF OF ELECTRICAL CURRENT FAILURE/POTENTIAL SHOCK HAZARD. THE LIM ALARMED AT 5000 MICROAMPS OR 5 MILLIAMPS. THE LEGAL LIMIT IN THE OR DURING OPEN HEART SURGERY IS 10 MICROAMPS. RPTR REFUSED TO MAKE ANY MODIFICATIONS WITH KIT & WAS ASKED TO LEAVE HIS POSITION AS A BIOMED ENGINEER. HE HAS BECOME AWARE THAT ANOTHER TECH IS MODIFYING MACHINES USING THESE KITS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOSLASH KIT SLUSH STIRRING ACCESSORY TO MODIFY COOLING DEVICE KDD O.R. SOLUTIONS, INC. ORS-K14LA

    Patients

    Seq Age Sex Outcome Treatment
    1 * TAYLOR ONE FREEZING BATH SER NO