BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTSTART MRX

    MDR report key: 2933076 · Received January 22, 2013

    Report

    Report Number
    1218950-2013-00211
    Event Type
    Injury
    Date Received
    January 22, 2013
    Report Date
    December 26, 2012
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT DURING A CODE, A THERAPY KNOB IOP MESSAGE WAS DISPLAYED. THE DEVICE STILL CHARGED AND SHOCKED AS EXPECTED. THERE WAS NO ADVERSE PATIENT IMPACT. THE 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 DURING A CODE, A THERAPY KNOB INOP MESSAGE WAS DISPLAYED. THE DEVICE STILL CHARGED AND SHOCKED AS EXPECTED. THERE WAS NO ADVERSE PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31527 HEARTSTART MRX MKJ PHILIPS MEDICAL SYSTEMS M3535A

    Patients

    Seq Age Sex Outcome Treatment
    1