BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTSTART MRX

    MDR report key: 3161558 · Received May 6, 2013

    Report

    Report Number
    1218950-2013-02183
    Event Type
    Injury
    Date Received
    May 6, 2013
    Report Date
    October 19, 2012
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS EVALUATED BY A PHILIPS FIELD SERVICE ENGINEER (FSE) AND THE SYMPTOM WAS NOT DUPLICATED. THE DEVICE PASSED ALL TESTING. THE CUSTOMER WAS PROVIDED INFO BY A PHILIPS PRODUCT SUPPORT ENGINEER (PSE) ON THE PROPER USE OF THE DEVICE. THERE IS NO INFO THAT SUPPORTS THAT THE DEVICE DID NOT MEET PRODUCT SPECIFICATIONS DURING THIS EVENT. THE DEVICE WAS USED OFF LABEL WITH NON-PHILIPS ACCESSORIES. THE MRX IFU STATES, "USE ONLY SUPPLIES AND ACCESSORIES APPROVED FOR USE WITH YOUR HEARTSTART MRX. USE OF NON-APPROVED SUPPLIES AND ACCESSORIES COULD AFFECT PERFORMANCE AND RESULTS." IN REVIEWING THIS COMPLAINT INVESTIGATION, A PROCESS ERROR WAS FOUND WHERE THE CUSTOMER REPORTED A SERIOUS INJURY AND THE COMPLAINT HAD NOT BEEN REPORTED.

    Description of Event or Problem · 1

    THE CUSTOMER HAS CLARIFIED ON (B)(6) 2012 THAT DURING TREATING OF ATRIAL FIBRILLATION WITH SYNC MODE THE PATIENT WENT INTO VENTRICULAR FIBRILLATION AS A RESULT OF THE MRX DELIVERING ENERGY AT A DIFFERENT POINT IN THE ECG WAVEFORM. A SUBSEQUENT SHOCK CONVERTED THE PATIENT RHYTHM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196716 HEARTSTART MRX MKJ PHILIPS MEDICAL SYSTEMS M3535A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention