BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 2263486 · Received September 16, 2011

    Report

    Report Number
    2263486
    Event Type
    Malfunction
    Date Received
    September 16, 2011
    Date of Event
    August 24, 2011
    Report Date
    September 16, 2011
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN, US

    Narratives

    Description of Event or Problem · 1

    RN WAS ASSESSING A CARDIAC RHYTHM WITH ST ELEVATION AND NOTIFIED THE PHYSICIAN. A 12 LEAD ELECTROCARDIOGRAM (ECG / EKG) TO RULE OUT MYOCARDIAL INFARCTION AND LABS WERE ORDERED. THE PATIENT WAS ASYMPTOMATIC. THE 12 LEAD ECG WAS UNCHANGED. THE NURSE CHECKED THE ECG CABLES FROM THE MONITOR AND DISCOVERED THAT THE CABLE HAD BEEN PLUGGED IN BACKWARDS. THE CABLE AND EKG LEADS MUST BE JOINED WITH THE TOP OF CONNECTOR ALIGNED WITH THE TOP OF THE TRUNK CABLE CONNECTOR. THERE IS A TAB WITH A GROOVE TO ENSURE PROPER JOINING OF THE TWO COMPONENTS. HOWEVER, IT IS POSSIBLE TO JOIN THE TWO COMPONENTS "UPSIDE DOWN" AND STILL GET WAVEFORMS ON THE MONITOR (THE WAVEFORMS WILL NOT BE ACCURATE WHEN JOINED IN REVERSE).AN INSPECTION OF THE CONNECTOR DEMONSTRATED A WEAR PATTERN WITH A GROOVE BEING WORN INTO THE BLUE CONTACT BODY ON THE CONNECTOR WHICH IS CONSISTENT WITH REPEATED ATTEMPTS TO INSERT THE CONNECTOR INTO THE TRUNK CABLE REVERSED. PHILIPS HEALTHCARE PROVIDES A COLOR-CODED LABEL WITH THE CABLES WHICH SHOULD BE ATTACHED TO THE TRUNK CABLE CONNECTOR PRIOR TO UTILIZING THE ECG CABLES. THERE WAS NO LABEL ATTACHED TO THE DAMAGED CABLE. AN INSPECTION OF OTHER DEVICES ON THE UNIT DEMONSTRATED ADDITIONAL DAMAGED CABLES AS WELL AS TRUNK CABLE CONNECTORS WITHOUT STICKERS.CENTRAL SUPPLY HAS IDENTIFIED THE TWO APPLICABLE PROCESSING POLICIES RELATED TO THIS DEVICE. INSPECTION WILL INCLUDE LOOKING FOR A BROKEN TAB WHICH WOULD PREVENT THE CABLE FROM BEING PLUGGED IN UPSIDE DOWN. BIOMEDICAL ENGINEERING STAFF NOTIFIED PHILIPS HEALTHCARE OF THE DESIGN ISSUE AND PROVIDED PICTURES OF THE EKG LEADS. PHILIPS HEALTHCARE IS INVESTIGATING AND CONTACTING THE PRODUCT LINE ENGINEERS TO RESEARCH PAST PROBLEMS AND PRESENT SITUATION. A MULTIDISCIPLINARY GROUP IS CONVENING TO ADDRESS ADDITIONAL MITIGATION STRATEGIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * MONITOR, PHYSIOLOGICAL, ECG CABLE SET MHX PHILIPS MEDICAL SYSTEMS M1968A 5

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR NO OTHER THERAPIES