BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART START XL

    MDR report key: 1833972 · Received August 31, 2010

    Report

    Report Number
    1218950-2010-01451
    Event Type
    Malfunction
    Date Received
    August 31, 2010
    Report Date
    August 4, 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): A PHYSICIAN WAS ATTEMPTING TO USE TWO HSXL DEFIBRILLATORS SIMULTANEOUSLY TO CARDIOVERT A PT. THE PHYSICIAN REPORTED THAT HE COULD NOT GET THE TWO DEFIBRILLATORS TO FIRE SIMULTANEOUSLY. THE PHYSICIAN WAS ABLE TO CARDIOVERT THE PT WITH ONE OF THE TWO DEFIBRILLATORS. THERE WAS NO NEGATIVE IMPACT TO THE PT. THUS USE MODEL IS NOT SUPPORTED, HOWEVER, WE ARE CONSIDERING THIS AS A MALFUNCTION (BASED ON THE CUSTOMER REPORT) WHILE THE INVESTIGATION CONTINUES. A F/U REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    A PHYSICIAN WAS ATTEMPTING TO USE TWO HSXL DEFIBRILLATORS. SIMULTANEOUSLY TO CARDIOVERT A PT. THE PHYSICIAN REPORTED THAT HE COULD NOT GET THE TWO DEFIBRILLATORS TO FIRE SIMULTANEOUSLY. THE PHYSICIAN WAS ABLE TO CARDIOVERT THE PT WITH ONE OF THE TWO DEFIBRILLATORS. THERE WAS NO NEGATIVE IMPACT TO THE 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