BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX

    MDR report key: 2170855 · Received June 22, 2011

    Report

    Report Number
    1218950-2011-01792
    Event Type
    Malfunction
    Date Received
    June 22, 2011
    Report Date
    May 25, 2011
    Manufacturer
    PHILIPS HEALTHCARE - ANDOVER
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT THE DEVICE DID NOT DELIVER A SHOCK TO A MANNEQUIN IN THE AED MODE USING PADS. THERE WAS NO PATIENT INVOLVEMENT. 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 CUSTOMER REPORTED THAT THE DEVICE DID NOT DELIVER A SHOCK TO A MANNEQUIN IN THE AED MODE USING PADS. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1