BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCUTORR PLUS

    MDR report key: 2002562 · Received January 28, 2011

    Report

    Report Number
    2221819-2011-00002
    Event Type
    Malfunction
    Date Received
    January 28, 2011
    Date of Event
    March 10, 2010
    Report Date
    November 30, 2010
    Manufacturer
    MIDRAY DS USA, INC.
    Product Code
    MHX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON LEARNING OF THE EVENT, MINDRAY REQUESTED THAT THE LINE CORD BE RETURNED TO THE FACTORY FOR EVALUATION. UPON RECEIPT OF THE CORD, MINDRAY ENGINEERING CONFIRMED THAT THE PRONG WAS MISSING AND THE PLUG SHOWED EVIDENCE OF BURNING. NO DATECODE WAS VISIBLE ON THE CORD, DUE TO THE MISSING PRONG. THE LINE CORD WAS THEN RETURNED TO THE VENDOR ELECTRI-CORD FOR EVALUATION. BASED ON THEIR ANALYSIS, THE MOLDED PLUG IN QUESTION IS AN ELECTRI-CORD ECM CATALOG NUMBER MC-10H WITH TALLER BLADES AND GROUND PIN. THE LINE BLADES CAN BREAK INSIDE THE MOLDED PLUG FROM EXTERNAL FORCES. THE BROKEN BLADES CAUSED ARCING TO OCCUR. ELECTRI-CORD ATTRIBUTES THE CAUSE OF THIS FAILURE TO ABUSE IN THE HOSPITAL ENVIRONMENT. ELECTRI-CORD HAS ADVISED MINDRAY THAT THERE ARE NO POWER CORDS WITH TALLER BLADES/GROUND PINS IN STOCK AT THEIR FACILITY. ELECTRI-CORD HAS DISCONTINUED THE USE OF THE CRIMPED STYLE TALLER BLADE IN ALL OF THEIR MOLDED PLUS. THESE HAVE BEEN REPLACED BY SOLDER TYPE BLADES/GROUND PINS THAT ARE MORE RESISTANT TO BREAKAGE. THE DISCONTINUATION OF THE USE OF THE TALLER BLADES/GROUND PIN IN THEIR CORDS WAS EFFECTIVE IN MID-AUGUST, 2009. ALL ELECTRI-CORD PRODUCTION NOW USES ALTERNATE STYLE BLADES WHICH ARE MORE RESISTANT TO MISUSE. ELECTRI-CORD REPORTED A 0.0012% FAILURE RATE FOR THE "TALLER BRIDGE" LINE CORDS. MINDRAY'S REPORTED FAILURE RATE FOR THIS FAILURE MODE IS ALSO VERY LOW - 0.006%. THEREFORE, NO ADDITIONAL CORRECTIVE ACTION IS PLANNED BY MINDRAY AT THIS TIME.

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE CUSTOMER'S BIOMED SAID THAT IN (B)(6) OF 2010, NURSES AT THE FACILITY OBSERVED THAT THE PRONG ON THE POWER CORD WAS BROKEN OFF, AND THERE WAS EVIDENCE OF CRACKING AND BURNING INSIDE THE PLUG. THE POWER CORD WAS USED WITH AN ACCUTORR PLUS MONITOR ON A ROLLING STAND. NO PATIENT WAS INVOLVED, AND NO INJURIES WERE REPORTED. THE BIOMED DID NOT KNOW THE SERIAL NUMBER OF THE MONITOR INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCUTORR PLUS NIBP MONITOR MHX MIDRAY DS USA, INC. ACCUTORR PLUS II NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK