BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX - EMS DEFIBRILLATOR

    MDR report key: 1874366 · Received October 11, 2010

    Report

    Report Number
    1218950-2010-01913
    Event Type
    Malfunction
    Date Received
    October 11, 2010
    Report Date
    September 13, 2010
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT THE DEVICE DID NOT RECOGNIZE PADS DURING A PACING EVENT. THE CUSTOMER STATED THAT THERE WAS NO NEGATIVE IMPACT FOR THE INVOLVED PT. PHILIPS EVALUATED THE DEVICE AND VERIFIED THE REPORTED SYMPTOM. THE THERAPY CABLE AND THE THERAPY PORT WERE REPLACED TO ADDRESS THE ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE DID NOT RECOGNIZE PADS DURING A PACING EVENT. THE CUSTOMER STATED THAT THERE WAS NO NEGATIVE IMPACT FOR THE INVOLVED PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTSTART MRX - EMS DEFIBRILLATOR MKJ PHILIPS HEALTHCARE M3536A

    Patients

    Seq Age Sex Outcome Treatment
    1