BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX

    MDR report key: 2963004 · Received February 14, 2013

    Report

    Report Number
    1218950-2013-00545
    Event Type
    Malfunction
    Date Received
    February 14, 2013
    Report Date
    November 8, 2012
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): PLEASE NOTE THAT ON (B)(4) 2012, WE SUBMITTED AN INITIAL MDR ((B)(4)) FOR THIS REPORTED PRODUCT PROBLEM. INADVERTENTLY THE INITIAL MDR WAS SUBMITTED UNDER AN INCORRECT REGISTRATION NUMBER. TO CORRECT THIS PROBLEM, WE HAVE CANCELED THAT INITIAL MDR, AND HAVE CREATED THIS NEW MDR ((B)(4)) WITH THE CORRECT REGISTRATION NUMBER. SINCE THE INVESTIGATION HAS BEEN COMPLETED, THIS NEWLY ISSUED MDR CONTAINS THE DETAILS AND RESULTS OF THE INVESTIGATION. A PHILIPS AUTHORIZED SUPPORT DISTRIBUTOR EVALUATED THE DEVICE AND VERIFIED THE FAILURE. THE ISSUE WAS DIAGNOSED AS AN AC POWER MODULE FAILURE. THE AC POWER MODULE WAS RECOMMENDED TO BE REPLACED TO RESOLVE THE ISSUE, BUT THE CUSTOMER DECLINED REPAIR. THE DEVICE REMAINED AT THE CUSTOMER SITE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE BATTERY IS NOT CHARGING AND EXTERNAL POWER IS "GETTING INTERRUPTED".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65729 HEARTSTART MRX MKJ PHILIPS MEDICAL SYSTEMS M3535A

    Patients

    Seq Age Sex Outcome Treatment
    1