BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX

    MDR report key: 2910668 · Received December 4, 2012

    Report

    Report Number
    1218950-2012-03992
    Event Type
    Malfunction
    Date Received
    December 4, 2012
    Report Date
    November 16, 2012
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THIS CUSTOMER REPORTED THAT WHILE PACING A PT, THE DEFIBRILLATOR STOPPED WORKING AND A "DEVICE ERROR, SERVICE REQUIRED" MESSAGE WAS GIVEN. THERE WAS NO NEGATIVE PT IMPACT RELATED TO THIS EVENT. THIS COMPLAINT IS STILL BEING INVESTIGATED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THIS CUSTOMER REPORTED THAT WHILE PACING A PT, THE DEFIBRILLATOR STOPPED WORKING AND A "DEVICE ERROR, SERVICE REQUIRED" MESSAGE WAS GIVEN. THERE WAS NO NEGATIVE PT IMPACT RELATED TO THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1