BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHILIPS MEDICAL SYSTEMS

    MDR report key: 2254761 · Received September 2, 2011

    Report

    Report Number
    MW5022251
    Event Type
    Injury
    Date Received
    September 2, 2011
    Date of Event
    March 31, 2011
    Report Date
    August 5, 2011
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    DPS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    THE HOSPITAL HAS PURCHASED 3 PHILIPS PAGEWRITER TC70 EKG MACHINES AND WE HAVE NOTICED SOME ISSUES WITH THEM THE LAST FEW MONTHS. THERE HAVE BEEN MULTIPLE FALSE POSITIVES (OVER 20 INCIDENCES) FOR CRITICAL VALUE INTERPRETATIONS OF: ACUTE MI; PT HAS PACEMAKER BUT ACTUALLY DOES NOT; FALSE NEGATIVE FOR ACUTE MI, (CAUGHT THIS DURING REVIEW OF EKG). I AM REPORTING THIS INSTANCE SINCE THIS OUTPATIENT CAME IN FOR PRE-OP EKG FOR VOCAL CORD SURGERY. THE CRITICAL VALUE INTERPRETED WAS ACUTE MI. THE PT WAS ADMITTED TO EMERGENCY TRAUMA ROOM. (B)(6) PERFORMED COMPLETE WORK UP FOR ACUTE MI, CHEST X-RAY; LAB WORK. (B)(6) NOTES: PT SENT OVER FROM OUTPATIENT FOR AN ABNORMAL EKG. PT WAS HAVING PRE-OP WORK DONE FOR A RIGHT VOCAL CORD SURGERY HE IS HAVING IN A FEW DAYS. PT DENIES ANY CP OR SYMPTOMS. UPON ER ARRIVAL PTS EKG IS NORMAL. (EKG USED IN (B)(6) WAS A GE MAC 5500). THE SCHEDULED SURGERY WAS POSTPONED DUE TO THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHILIPS MEDICAL SYSTEMS EKG UNIT DPS PHILIPS MEDICAL SYSTEMS PAGEWRITER TC70
    2 PHILIPS MEDICAL SYSTEMS EKG UNIT DPS PHILIPS MEDICAL SYSTEMS PAGEWRITER TC70
    3 PHILIPS MEDICAL SYSTEM EKG UNIT DPS PHILIPS MEDICAL SYSTEMS PAGEWRITER TC70

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization