BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART START XL

    MDR report key: 1841463 · Received September 16, 2010

    Report

    Report Number
    1218950-2010-01621
    Event Type
    Malfunction
    Date Received
    September 16, 2010
    Report Date
    August 17, 2010
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THIS CUSTOMER REPORTED THAT THE NURSES DID NOT SEE THE R-WAVE MARKERS AS EXPECTED WHEN THEY WANTED TO DELIVER SYNCHRONIZED CARDIOVERSION. THEY SWITCHED TO A DIFFERENT MODEL OF DEFIBRILLATOR TO DELIVER SYNCHRONIZED CARDIOVERSION. THERE WAS NO IMPACT TO THE INVOLVED PT. THE HOSP BIOMEDICAL ENGINEER EVALUATED THE DEVICE AND IT PASSED ALL TESTING. THE CUSTOMER WAS PROVIDED INFO RELATED TO THE PLACEMENT OF THE SYNCHRONIZED MARKER ON THE DISPLAY AND ON THE PRINTED STRIP. THE DEVICE WAS BEHAVING AS DESIGNED AND INTENDED. WE ARE CONSIDERING THIS TO BE A USER MISUNDERSTANDING RELATED TO PLACEMENT OF THE SYNCHRONIZED MARKER.

    Description of Event or Problem · 1

    THIS CUSTOMER REPORTED THAT THE NURSES DID NOT SEE THE R-WAVE MARKERS AS EXPECTED WHEN THEY WANTED TO DELIVER SYNCHRONIZED CARDIOVERSION. THEY SWITCHED TO A DIFFERENT MODEL OF DEFIBRILLATOR TO DELIVER SYNCHRONIZED CARDIOVERSION. THERE WAS NO IMPACT TO THE INVOLVED PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEART START XL MKJ PHILIPS HEALTHCARE M4735A

    Patients

    Seq Age Sex Outcome Treatment
    1