BEUDAMED
    FDA Adverse Event Other Summary report: N

    HEWLETT PACKARD PAGE WRITER XLI

    MDR report key: 425484 · Received October 29, 2002

    Report

    Report Number
    MW1026578
    Event Type
    Other
    Date Received
    October 29, 2002
    Date of Event
    May 9, 2002
    Report Date
    October 29, 2002
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    DPS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT COMPLAINING OF CHEST PAIN. STAT EKG ORDERED. THE EKG SHOWED A WIDE QRS ON THE 12 LEAD EKG. CARDIOLOGY CONSULTED. HEART CATH PERFORMED WITH NO INTERVENTIONS NEEDED. UPON RE-REVIEW OF THE EKG POST-PRODEDURE IT WAS NOTED THAT THE EKG WAS DONE AT 50 MM/SEC INSTEAD OF 25 MM/SEC. THE BUTTON ON THE LEFT SIDE OF THE PANEL THAT CONTROLS THE SPEED WAS INADVERTENTLY BUMPED DURING PAPER CHANGE. THIS CAUSED THE SPEED TO INCREASE FROM 25 MM/SEC TO 50 MM/SEC. THESE CONTROL BUTTONS DO NOT HAVE A PROTECTIVE COVER. ADDITIONALLY THE PROCESS TO CHANGE THE SPEED IS A ONE-STEP PROCESS. DEVICE MAY BE EVALUATED ON SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEWLETT PACKARD PAGE WRITER XLI EKG MACHINE DPS PHILIPS MEDICAL SYSTEMS M1700A *

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other