BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHILIPS MEDICAL

    MDR report key: 1362991 · Received April 13, 2009

    Report

    Report Number
    MW5010745
    Event Type
    Malfunction
    Date Received
    April 13, 2009
    Date of Event
    January 29, 2009
    Report Date
    March 26, 2009
    Manufacturer
    PHHILIPS ELECTRONICS NORTH AMERICA CORP.
    Product Code
    MHX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PINS WERE BENT ON THIS MONITOR DUE TO THE PINS ON THE PHILIPS MMS MODULE. THE BENT PINS CAUSE THE MONITOR TO BE INOPERABLE. THIS SITUATION PRESENTS THE POTENTIAL FOR PATIENT SAFETY ISSUES, AS HEALTH CARE PROVIDERS NEED ACCESS TO IMMEDIATE MONITORING OF UNSTABLE PATIENTS THAT ARE BROUGHT TO CRITICAL CARE AREAS. THE BIOMEDICAL TECHNICIAN REPLACED THE NECESSARY COMPONENTS, TESTED THE DEVICE, AND RETURNED IT TO SERVICE. THE DEVICE IS AVAILABLE FOR ONSITE EVALUATION AT OUR FACILITY. QUESTIONS AND COMMENTS SHOULD BE DIRECTED TO THE BIOMEDICAL DIRECTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHILIPS MEDICAL PHYSIOLOGICAL MONITOR MHX PHHILIPS ELECTRONICS NORTH AMERICA CORP. M8002A

    Patients

    Seq Age Sex Outcome Treatment
    1