BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX

    MDR report key: 1853653 · Received September 29, 2010

    Report

    Report Number
    1218950-2010-01746
    Event Type
    Malfunction
    Date Received
    September 29, 2010
    Report Date
    August 31, 2010
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CLINICAL STAFF REPORTED THAT THEY HEARD AED PROMPTS WHILE IN THE MANUAL MODE AND WOULD NOT ALLOW SHOCK. THERE WAS NO IMPACT TO THE INVOLVED PT. THIS COMPLAINT IS STILL BEING INVESTIGATED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE CLINICAL STAFF REPORTED THAT THEY HEARD AED PROMPTS WHILE IN THE MANUAL MODE AND WOULD NOT ALLOW SHOCK. THERE WAS NO IMPACT TO THE INVOLVED PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTSTART MRX MKJ PHILIPS HEALTHCARE M3535A

    Patients

    Seq Age Sex Outcome Treatment
    1